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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Class IIMedicationMar 17, 2026
Chiesi USA, Inc.: CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Lack of Assurance of Sterility
Product, lots & distribution
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen Interna…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. — Distribution: Nationwide in the USA — Lots/codes: Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen Interna…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. — Distribution: Nationwide in the USA — Lots/codes: Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen Interna…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. — Distribution: Nationwide in the USA — Lots/codes: Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Viatris, Inc.: Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
Failed Dissolution Specifications
Product, lots & distribution
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91 — Distribution: US Nationwide. — Lots/codes: Lot# 8177156, Exp Date: 02/28/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 17, 2026
Nephron SC, LLC: Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Colu…
Labelling: Illegible label
Product, lots & distribution
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05. — Distribution: Nationwide within the United States — Lots/codes: Lot AB6001, exp date 1/15/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Amerisource Health Services LLC: Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: Ame…
Failed tablet specifications.
Product, lots & distribution
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Distribution: U.S. Nationwide — Lots/codes: Lot #1024852; Exp 9/30/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boul…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boul…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 16, 2026
Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boul…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Product, lots & distribution
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 13, 2026
Cipla USA, Inc.: Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greec…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Product, lots & distribution
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 13, 2026
Cipla USA, Inc.: Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for:…
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Product, lots & distribution
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67 — Distribution: Nationwide in the USA — Lots/codes: Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 4401725IR1, Exp. 5/31/2026; 4401732IR1, Exp. 5/31/2026; 4401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 11/30/2026; 4401787IR1, Exp. 11/30/2026; 4401815IR1, Exp. 11/30/2026; 4401816IR1, Exp. 11/30/2026; 4401834IR1, Exp. 11/30/2026; 4401835IR1, Exp. 11/30/2026; 4401846IR1, Exp. 11/30/2026; 4401851IR1, Exp. 11/30/2026; 4500017IR1, Exp. 12/31/2026; 4500031IR1, Exp. 1… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 13, 2026
ENDO USA, Inc.: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Crystallization; identified as Buprenorphine free base
Product, lots & distribution
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05. — Distribution: USA Nationwide — Lots/codes: Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zuric…
Lack of Assurance of Sterility
Product, lots & distribution
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch # 6402413, Exp Date: 02/29/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC:…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich,…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius K…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distribut…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin…
Lack of Assurance of Sterility
Product, lots & distribution
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 24EU10010, Exp Date: 05/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of S…
Lack of Assurance of Sterility
Product, lots & distribution
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402296, Exp Date: 07/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of S…
Lack of Assurance of Sterility
Product, lots & distribution
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 11, 2026
Fresenius Kabi USA, LLC: 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit o…
Lack of Assurance of Sterility
Product, lots & distribution
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30. — Distribution: US Nationwide , Alaska, and Puerto Rico. — Lots/codes: Batch# 6402165, Exp Date: 05/30/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 9, 2026
Zydus Pharmaceuticals (USA) Inc: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA)…
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Product, lots & distribution
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7 — Distribution: Nationwide in the USA — Lots/codes: Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr — Status: Ongoing (voluntary: firm initiated)