FDA · food & medication · last 6 months

The recall log.

Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.

326 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM

Class IIMedicationApr 2, 2026

Huons Co., Ltd.: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheong…

Lack of Assurance of Sterility

Product, lots & distribution

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules) — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0530-2026 · 3,260,170 ampules

Class IIMedicationApr 2, 2026

Huons Co., Ltd.: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd…

Lack of Assurance of Sterility

Product, lots & distribution

0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0531-2026 · 7,120,750 ampules

Class IIMedicationApr 2, 2026

Huons Co., Ltd.: Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, ND…

Lack of Assurance of Sterility

Product, lots & distribution

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton) — Distribution: USA Nationwide. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0532-2026 · N/A

Class IIMedicationApr 1, 2026

International Medication Systems Ltd.: EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Compa…

Lack of Assurance of Sterility

Product, lots & distribution

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1 — Distribution: U.S. Nationwide — Lots/codes: Lot Number: EA038A5, Expiration Date: 08/2026. — Status: Ongoing (voluntary: firm initiated)

D-0483-2026 · 81,520 units

Class IIMedicationApr 1, 2026

Island Kinetics, Inc. d.b.a. CoValence Laboratories: Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

Failed Stability Specifications

Product, lots & distribution

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9. — Distribution: U.S. Nationwide — Lots/codes: Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027 — Status: Ongoing (voluntary: firm initiated)

D-0487-2026 · 28,163 bottles

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

cGMP deviations.

Product, lots & distribution

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03 — Distribution: U.S. Nationwide. — Lots/codes: 120325122032719, Exp Date 04/03/2026, 120425122032734 Exp Date 04/04/2026, 120425122032735, Exp Date 04/04/2026, 120925122032781, Exp Date 04/10/2026, 010626122030010, Exp Date, 05/08/2026, 010626122030009, Exp Date 05/08/2026, 010826122030031, Exp Date 05/13/2026, 010826122030032, Exp Date 05/13/2026, 011326122030072, Exp Date 05/15/2026, 011326122030071, Exp Date 05/15/2026, 011626122030107, Exp Date 05/20/2026, 011626122030106, Exp Date 05/20/2026, 011926122030118, Exp. Date, 05/21/2026, 011926122030119, Exp Date, 05/21/2026, 012726122030171, Exp Date, 05/29/2026, 012726122030170, Exp Date… — Status: Ongoing (voluntary: firm initiated)

D-0502-2026 · 13,070 IV Bags

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02. — Distribution: U.S. Nationwide. — Lots/codes: 120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026 — Status: Ongoing (voluntary: firm initiated)

D-0503-2026 · 4,030 IV Bags

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03. — Distribution: U.S. Nationwide. — Lots/codes: 120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/… — Status: Ongoing (voluntary: firm initiated)

D-0504-2026 · 2940 IV Bags

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25. — Distribution: U.S. Nationwide. — Lots/codes: Lot 011226204250063, Exp Date 05/14/2026 — Status: Ongoing (voluntary: firm initiated)

D-0505-2026 · 50 syringes

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65. — Distribution: U.S. Nationwide. — Lots/codes: Lot 022326203650432; Exp Date 06/25/2026 — Status: Ongoing (voluntary: firm initiated)

D-0506-2026 · 150 syringes

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

cGMP deviations.

Product, lots & distribution

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31. — Distribution: U.S. Nationwide. — Lots/codes: 120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026. — Status: Ongoing (voluntary: firm initiated)

D-0507-2026 · 4975 syringes

Class IIMedicationApr 1, 2026

Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

cGMP deviations.

Product, lots & distribution

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15. — Distribution: U.S. Nationwide. — Lots/codes: Lot 020226202150202, Exp Date 05/05/2026. — Status: Ongoing (voluntary: firm initiated)

D-0508-2026 · 50 syringes

Class IIIMedicationMar 31, 2026

Avantor Performance Materials LLC: Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite…

Subpotent drug

Product, lots & distribution

Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1 — Distribution: Nationwide in the USA, Belgium and France — Lots/codes: Lot 23G3161005, Exp 9/21/2027 — Status: Ongoing (voluntary: firm initiated)

D-0488-2026 · 36 bottles

Class IIMedicationMar 27, 2026

Appco Pharma LLC: Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-…

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Product, lots & distribution

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN. — Status: Ongoing (voluntary: firm initiated)

D-0419-2026 · 88,008 bottles- 100's count

Class IIMedicationMar 27, 2026

Appco Pharma LLC: Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-…

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Product, lots & distribution

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY. — Status: Ongoing (voluntary: firm initiated)

D-0420-2026 · 58,896 bottles- 100's count

Class IIMedicationMar 27, 2026

Appco Pharma LLC: Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-…

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Product, lots & distribution

Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. . — Status: Ongoing (voluntary: firm initiated)

D-0421-2026 · 28,157 bottles- 100's count

Class IIMedicationMar 26, 2026

Hetero Labs Limited (Unit V): Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, H…

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Product, lots & distribution

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10 — Distribution: Nationwide in the USA. — Lots/codes: Batch # FD253967, Exp Date: 06/26/2027 — Status: Ongoing (voluntary: firm initiated)

D-0484-2026 · 4,740 1,000-count bottles.

Class IIMedicationMar 25, 2026

Preferred Pharmaceuticals, Inc.: Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266…

Lack of Assurance of Sterility

Product, lots & distribution

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0 — Distribution: Nationwide within the United States — Lots/codes: Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M — Status: Ongoing (voluntary: firm initiated)

D-0443-2026 · 720 bottles

Class IIMedicationMar 25, 2026

SUN PHARMACEUTICAL INDUSTRIES INC: Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc.…

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Product, lots & distribution

Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1 — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76252, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0475-2026 · 24,672 15 g tubes

Class IIMedicationMar 25, 2026

SUN PHARMACEUTICAL INDUSTRIES INC: Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc.…

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Product, lots & distribution

Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2. — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76251, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0476-2026 · 41,712 30g tubes

Class IIMedicationMar 25, 2026

SUN PHARMACEUTICAL INDUSTRIES INC: Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc.…

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Product, lots & distribution

Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3. — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76250, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0477-2026 · 2,640 60g tubes

Class IIMedicationMar 24, 2026

GE Healthcare Ireland Limited: GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

Presence of particulate matter

Product, lots & distribution

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63. — Distribution: U.S. Nationwide. — Lots/codes: Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028… — Status: Ongoing (voluntary: firm initiated)

D-0447-2026 · 866,570 vials

Class IIMedicationMar 24, 2026

GE Healthcare Ireland Limited: GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

Presence of particulate matter

Product, lots & distribution

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91. — Distribution: U.S. Nationwide. — Lots/codes: Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029 — Status: Ongoing (voluntary: firm initiated)

D-0448-2026 · 306,810 vials

Class IIMedicationMar 24, 2026

The Harvard Drug Group LLC: Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis,…

Failed Dissolution Specifications

Product, lots & distribution

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61 — Distribution: US Nationwide. — Lots/codes: Lot # N02425, Exp Date: 05/31/2027. — Status: Ongoing (voluntary: firm initiated)

D-0485-2026 · N/A

Class IIMedicationMar 20, 2026

Fagron Compounding Services: norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Product, lots & distribution

norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026. — Status: Ongoing (voluntary: firm initiated)

D-0438-2026 · 25,260 bags

Class IIMedicationMar 20, 2026

Fagron Compounding Services: norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Product, lots & distribution

norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026. — Status: Ongoing (voluntary: firm initiated)

D-0439-2026 · 5140 bags

Class IIMedicationMar 20, 2026

Fagron Compounding Services: Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Product, lots & distribution

Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026. — Status: Ongoing (voluntary: firm initiated)

D-0440-2026 · 34,260 bags

Class IIMedicationMar 20, 2026

Fagron Compounding Services: Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Product, lots & distribution

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026. — Status: Ongoing (voluntary: firm initiated)

D-0441-2026 · 16,130 bags

Class IIMedicationMar 20, 2026

Fagron Compounding Services: Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Product, lots & distribution

Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026. — Status: Ongoing (voluntary: firm initiated)

D-0442-2026 · 11,680 bags

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By:…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)

D-0456-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Med…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)

D-0457-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)

D-0458-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medi…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)

D-0459-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 4425…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085. — Distribution: US Nationwide. — Lots/codes: Lot # 20241030, Exp Date: 10/30/2026 — Status: Ongoing (voluntary: firm initiated)

D-0460-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 10…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085 — Distribution: US Nationwide. — Lots/codes: Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0461-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier C…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047. — Distribution: US Nationwide. — Lots/codes: Lot# 20240524, Exp Date: 05/24/2026. — Status: Ongoing (voluntary: firm initiated)

D-0462-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier C…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030. — Distribution: US Nationwide. — Lots/codes: Lot# 20240730, Exp Date: 07/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0463-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., N…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot# 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)

D-0464-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot # 20240524, Exp Date: 05/24/2026; Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)

D-0465-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Nov…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026, Lot # 20241030, Exp Date: 10/30/2026. — Status: Ongoing (voluntary: firm initiated)

D-0466-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Mad…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)

D-0467-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375,…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)

D-0468-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026; Lot # 20240524, Exp Date: 05/24/2026. — Status: Ongoing (voluntary: firm initiated)

D-0469-2026 · N/A

Class IIMedicationMar 20, 2026

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.: QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375…

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

Product, lots & distribution

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411. — Distribution: US Nationwide. — Lots/codes: Lot # 20240720, Exp Date: 07/20/2026. — Status: Ongoing (voluntary: firm initiated)

D-0470-2026 · N/A

Class IIMedicationMar 20, 2026

Leading Pharma, LLC: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Product, lots & distribution

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 — Distribution: US Nationwide. — Lots/codes: Lots# H03125, H03225, H03325, Exp Date: 2027/08 — Status: Ongoing (voluntary: firm initiated)

D-0486-2026 · 9384 bottles

Class IIMedicationMar 19, 2026

Amneal Pharmaceuticals, LLC: traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal…

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

Product, lots & distribution

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5. — Distribution: Nationwide within the USA — Lots/codes: Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026. — Status: Ongoing (voluntary: firm initiated)

D-0408-2026 · 29,542 bottles

Class IIMedicationMar 19, 2026

Teva Pharmaceuticals USA, Inc: Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake…

CGMP Deviations: use of an unapproved raw material

Product, lots & distribution

Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027. — Status: Ongoing (voluntary: firm initiated)

D-0472-2026 · 124,054 Cartons

Class IIMedicationMar 19, 2026

Teva Pharmaceuticals USA, Inc: Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake…

CGMP Deviations: use of an unapproved raw material

Product, lots & distribution

Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 — Status: Ongoing (voluntary: firm initiated)

D-0473-2026 · 62,136 Cartons

Class IIMedicationMar 19, 2026

Teva Pharmaceuticals USA, Inc: Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake…

CGMP Deviations: use of an unapproved raw material

Product, lots & distribution

Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch — Distribution: Within U.S — Lots/codes: Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027. — Status: Ongoing (voluntary: firm initiated)

D-0474-2026 · 113,943 Cartons

Class IMedicationMar 18, 2026

Amneal Pharmaceuticals, LLC: Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals…

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

Product, lots & distribution

Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3. — Distribution: U.S.A. Nationwide — Lots/codes: Lot: AH250162, Exp 8/31/2027 — Status: Ongoing (voluntary: firm initiated)

D-0478-2026 · 784 (12x100mL) cartons

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