Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 9…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidi…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
CareFusion 213, LLC: BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subs…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product, lots & distribution
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS. — Distribution: Distributed Nationwide in the USA — Lots/codes: Lot: 4190081, Exp 06/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 11, 2026
BioMed Laboratories, LLC.: Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13…
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Product, lots & distribution
Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04 — Distribution: Nationwide in the US — Lots/codes: Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 11, 2026
Wondermade LLC: Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box
Foreign material: small metal pieces
Product, lots & distribution
Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed cardboard box — Distribution: Product was distributed to PA, TX, IN, FL — Lots/codes: Expiration Date: July 28,2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 10, 2026
ACCORD BIOPHARMA INC: IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, N…
Lack of assurance of Sterility:
Product, lots & distribution
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26. — Distribution: US Nationwide. — Lots/codes: Lot # 004L24A, Exp Date: 02/19/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 10, 2026
McKesson: Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Gosla…
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Product, lots & distribution
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01 — Distribution: Nationwide within the United States — Lots/codes: Lot #: CB0046, Exp. Date 06/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 10, 2026
Fry Pie Factory LLC: Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041
Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)
Product, lots & distribution
Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 601959803041 — Distribution: OH, WV — Lots/codes: Sell by dates 061226 through 062126 — Status: Completed (voluntary: firm initiated)
Class IIFoodJun 10, 2026
Wells Enterprises, Inc.: Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A WELLS DAIRY, INC., P.O. BOX 1310 LE…
Elevated coliforms
Product, lots & distribution
Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A WELLS DAIRY, INC., P.O. BOX 1310 LE MARS, IA 51031 — Distribution: One customer located in Kenosha, WI — Lots/codes: Pallet LPN: L7396434 Product lot code: 60003 JJJ 19115 18:00 6098 Best If Used By 10/07/27 — Status: Ongoing (voluntary: firm initiated)
Class IFoodJun 9, 2026
GREENWORLD FOOD EXPRESS (USA) LLC: Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case
Product may be contaminated with Salmonella
Product, lots & distribution
Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case — Distribution: MI, NY — Lots/codes: LOT 13286 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 8, 2026
ACCORD HEALTHCARE, INC.: Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmace…
Subpotent Drug
Product, lots & distribution
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15. — Distribution: US Nationwide. — Lots/codes: Lot # D2401522, Exp Date: 06/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 8, 2026
Asclemed USA Inc.: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-…
Lack of Assurance of Sterility
Product, lots & distribution
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01. — Distribution: USA Nationwide — Lots/codes: Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 8, 2026
Asclemed USA Inc.: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.
Lack of Assurance of Sterility
Product, lots & distribution
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. — Distribution: USA Nationwide — Lots/codes: Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 7, 2026
ONESOURCE SPECIALTY PHARMA LIMITED: Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufa…
Failed Impurities/Degradation Specifications
Product, lots & distribution
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 7000612A, Exp. Date 1/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 5, 2026
Inventia Healthcare Limited: Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (Eas…
Failed Dissolution Specifications
Product, lots & distribution
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10 — Distribution: U.S. Nationwide. — Lots/codes: [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 5, 2026
Le Chef Bakery: Le Chef Bakery branded Mini Italian Pastry Assortment; 2.5 lbs/cs; (40 pieces/cs); packaged in generic food service packaging with white label. UPC: MP006
undeclared colors (yellow#5)
Product, lots & distribution
Le Chef Bakery branded Mini Italian Pastry Assortment; 2.5 lbs/cs; (40 pieces/cs); packaged in generic food service packaging with white label. UPC: MP006 — Distribution: Recalled products are intended for commercial and institution use. Examples are hotels, universities, and buisnesses in the south-west states of California, Arizona and Nevada. — Lots/codes: Julian Dates 3355 to 1536 (mfg. dates: 12/01/2025 to 06/02/2026) — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, D…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product, lots & distribution
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 — Distribution: Nationwide within the United States — Lots/codes: Lot: 241180C, Exp. Date April 2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutica…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product, lots & distribution
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. — Distribution: Nationwide within the United States — Lots/codes: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027. — Status: Ongoing (voluntary: firm initiated)
Class IMedicationJun 4, 2026
Haleon US Holdings LLC: Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07…
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Product, lots & distribution
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. — Distribution: Nationwide within the United States — Lots/codes: Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made…
Presence of Foreign Substance.
Product, lots & distribution
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. — Distribution: Nationwide within the United States — Lots/codes: a) Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027 b) Lot #1138201, 1138202, 08/31/2026, 1138900, 1141143, Exp. Date 08/31/2026; 1140280, 1140281, 1142063, Exp. Date 10/31/2026; 1142062, 1142942, 1142943, Exp. Date 11/30/2026; 1144081, 1144104, Exp. Date 12/31/2026; 1146373, 1146374, Exp. Date 01/31/2027; 1147491, 1147492, 1149843, Exp. Date 03/31/2027; 1151113, 1151890, 1153401, Exp. Date 07/31/2027; 1151114, 1151115, Exp. Date 09/30/2027; 1152412, 1153399, 1153400, Exp. Date 06/30/2027; 1155834, 1155835, Exp. Date 04/30/2027; 1155836, Exp. Date 09/30/2027; 1158480, 115848… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
CGMP Deviations
Product, lots & distribution
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 — Distribution: Nationwide within the United States — Lots/codes: Lot#: 1156858, Exp. Date 12/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
CGMP Deviations
Product, lots & distribution
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1157055, Exp. Date 1/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Presence of Foreign Substance.
Product, lots & distribution
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Amgen, Inc.: Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
CGMP Deviations
Product, lots & distribution
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1157056, Exp. Date 02/29/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Annora Pharma Private Limited: Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceutica…
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Product, lots & distribution
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60. — Distribution: Nationwide in the USA — Lots/codes: Lot: A253999, A254000, Expires: 09/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Elevate Oral Care: Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
sub potency
Product, lots & distribution
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. — Distribution: Nationwide — Lots/codes: Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 4, 2026
Lupin Pharmaceuticals Inc.: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: L…
Presence of Foreign Substance
Product, lots & distribution
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA — Distribution: U.S. Nationwide — Lots/codes: Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Expires: 10/31/2026; HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298, Expires: 11/30/2026; HB00002, HB00004, HB00006, HB00017, HB00019, HB0… — Status: Ongoing (voluntary: firm initiated)
Class IIFoodJun 4, 2026
W.Y. Industries, Inc.: WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case.
Product may contain metal fragments.
Product, lots & distribution
WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case. — Distribution: The adulterated product was distributed to the following states : NY, NJ, OH, PA — Lots/codes: UPC codes: 015051010021 Lot code*: 152, after 15:00; 153, any time — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationJun 3, 2026
Amneal Pharmaceuticals, LLC: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distri…
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Product, lots & distribution
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 — Distribution: Nationwide within the USA. — Lots/codes: Lot AM251676, EXP 11/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodJun 3, 2026
Mothers' Milk Bank of Louisiana at Ochsner Baptist: MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein, packaged in a clear plastic bottle with white plastic cap
Potential physical contamination: dark spot was noticed on the bottom of container.
Product, lots & distribution
MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein, packaged in a clear plastic bottle with white plastic cap — Distribution: LA — Lots/codes: Batch: 002307-1, 002307-2 EXP: 08/24/2026 — Status: Terminated (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Central Admixture Pharmacy Services, Inc.: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dos…
Incorrect product formulation: bag did not contain copper and famotidine per label.
Product, lots & distribution
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767. — Distribution: MA — Lots/codes: 24-1269856-0-1 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationJun 2, 2026
ANI Pharmaceuticals, Inc.: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Presence of foreign substance
Product, lots & distribution
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 — Distribution: Nationwide in the USA — Lots/codes: Lot S25133A — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5. — Distribution: US Nationwide. — Lots/codes: Lot# 0001, 0002, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufact…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4. — Distribution: US Nationwide. — Lots/codes: Lot# 0002, Lot# 0003, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0. — Distribution: US Nationwide. — Lots/codes: Lot# 0001, and Lot# 0005, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8. — Distribution: US Nationwide. — Lots/codes: Lot# 0005, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: P…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9. — Distribution: US Nationwide. — Lots/codes: Lot# 0004, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1. — Distribution: US Nationwide. — Lots/codes: Lot# 0003, within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UP…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4. — Distribution: US Nationwide. — Lots/codes: Lot# 007, 008, 009, 015, 016, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 003, 004, 005, 006, 010, 011, 012, 013, 014, 016, 017, 018, 019, 020, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LK…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT. — Distribution: US Nationwide. — Lots/codes: Lot# 022, 023 ,024, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061. — Distribution: US Nationwide. — Lots/codes: Lot# 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 014, 015, 017, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 034, 035, 036, 037, 038, 039, 041, 042, 043, 044, 048, 049, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 013, 016, 031, 032, 033, 045, 046, 047, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufact…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1. — Distribution: US Nationwide. — Lots/codes: Lot# 011, 014, 015, 016, 017, 018, 019, 020, 021, 022, 026, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 2, 2026
Dabur India Limited: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Roa…
CGMP Deviations; deficiencies observed during FDA inspection
Product, lots & distribution
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8. — Distribution: US Nationwide. — Lots/codes: Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 023, 024, 025, 027, 028, 029, 031, 032, 033, 034, 035, Within Expiry. — Status: Ongoing (voluntary: firm initiated)
Class IFoodJun 2, 2026
Prime Food Processing LLC.: Dried Herring Fish 7 oz.
Improperly eviscerated which may result in Clostridium botulinum contamination
Product, lots & distribution
Dried Herring Fish 7 oz. — Distribution: AZ, CA, FL, HI, IL, KS, LA, MD, MO, NC, NH, NV, NY, OK, OR, PA, TX, UT, WA — Lots/codes: Lot Code: 26020. Expiration: 06.12.28 UPC Codes: 6946976817911 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationJun 1, 2026
Ascend Laboratories, LLC: Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratori…
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Product, lots & distribution
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30 — Distribution: Nationwide in the USA — Lots/codes: Lot# 25141635, Exp 4/30/2028 — Status: Ongoing (voluntary: firm initiated)