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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 681–700 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

by The Harvard Drug Group LLC

Reason
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Recall initiated
October 10, 2025
Reported by FDA
October 29, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01

by Rising Pharma Holding, Inc.

Reason
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Recall initiated
October 7, 2025
Reported by FDA
October 22, 2025
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30

by ASTRAZENECA PHARMACEUTICALS

Reason
Lack of Assurance of Sterility:
Recall initiated
October 8, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide in the U.S

View recall →

Drug Recall Ongoing Historical recordClass II

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

by Amerisource Health Services LLC

Reason
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Recall initiated
October 9, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91

by ENDO USA, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Recall initiated
September 5, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass III

FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.

by STAQ Pharma, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
October 9, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass III

Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.

by STAQ Pharma, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
October 9, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass III

Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.

by STAQ Pharma, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
October 9, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344

by SV Labs Prescott Corporation

Reason
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Recall initiated
September 25, 2025
Reported by FDA
October 22, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Impurities/Degradation Specifications
Recall initiated
September 3, 2025
Reported by FDA
October 22, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
September 19, 2025
Reported by FDA
October 22, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
September 19, 2025
Reported by FDA
October 22, 2025
Distribution
U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
September 19, 2025
Reported by FDA
October 22, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications
Recall initiated
September 19, 2025
Reported by FDA
October 22, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.

by VIONA PHARMACEUTICALS INC

Reason
Discoloration
Recall initiated
October 6, 2025
Reported by FDA
October 22, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass I

Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1

by IntegraDose Compounding Services LLC

Reason
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Recall initiated
September 16, 2025
Reported by FDA
October 22, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

by GenoGenix LLC

Reason
Microbial Contamination of Sterile Products: elevated endotoxin levels
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.

by GenoGenix LLC

Reason
Lack of Assurance of Sterility
Recall initiated
July 30, 2025
Reported by FDA
October 15, 2025
Distribution
US Nationwide.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.