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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 41–60 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3

by Apotex Corp.

Reason
Failed dissolution specifications.
Recall initiated
September 23, 2026
Reported by FDA
October 7, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

by Par Health USA, LLC

Reason
Crystallization
Recall initiated
September 8, 2026
Reported by FDA
October 7, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.

by TerSera Therapeutics LLC

Reason
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
Recall initiated
August 31, 2026
Reported by FDA
October 7, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass II

FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19

by Aurolab Trust

Reason
Lack of Assurance of Sterility
Recall initiated
September 17, 2026
Reported by FDA
October 7, 2026
Distribution
VA

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Drug Recall Ongoing 2026 recordClass II

Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.

by Amneal Pharmaceuticals, LLC

Reason
Defective Container; packets were found to be either empty or partially full.
Recall initiated
September 8, 2026
Reported by FDA
October 7, 2026
Distribution
Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass II

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

by Ajanta Pharma USA Inc

Reason
Failed Dissolution Specifications: below specification
Recall initiated
September 17, 2026
Reported by FDA
October 7, 2026
Distribution
Nationwide in the US.

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Drug Recall Ongoing 2026 recordClass II

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15

by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Reason
Lack of Assurance of Sterility
Recall initiated
September 15, 2026
Reported by FDA
September 30, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15

by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Reason
Lack of Assurance of Sterility
Recall initiated
September 15, 2026
Reported by FDA
September 30, 2026
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing 2026 recordClass II

Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1

by Amneal Pharmaceuticals of New York, LLC

Reason
Defective Delivery System: Possibility of no medication in the prefilled pen.
Recall initiated
August 28, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass III

Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.

by Macleods Pharmaceuticals Limited

Reason
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Recall initiated
August 27, 2026
Reported by FDA
September 30, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15

by Sterling Pharmaceutical Services LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 20, 2026
Reported by FDA
September 30, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China

by SHANTOU Qiwei industrial Co., Ltd

Reason
cGMP Deviations
Recall initiated
August 8, 2026
Reported by FDA
September 30, 2026
Distribution
CA only

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.

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