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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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Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30

by Astral SteriTech Private Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: May 15, 2023
Reported by FDA: May 24, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

by Astral SteriTech Private Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: May 15, 2023
Reported by FDA: May 24, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02

by Astral SteriTech Private Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: May 15, 2023
Reported by FDA: May 24, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41

by Astral SteriTech Private Ltd.

Reason: Lack of Assurance of Sterility
Recall initiated: May 15, 2023
Reported by FDA: May 24, 2023
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05

by Sanofi-Aventis U.S. LLC

Reason: Lack of Assurance of Sterility: Malformed crimped collar seal
Recall initiated: April 11, 2023
Reported by FDA: May 24, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61

by The Harvard Drug Group

Reason: Product mixup: one foreign tablet found in product.
Recall initiated: April 24, 2023
Reported by FDA: May 17, 2023
Distribution: USA Nationwide

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Drug Recall Completed Historical recordClass II

Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6

by Apotex Corp.

Reason: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Recall initiated: April 26, 2023
Reported by FDA: May 17, 2023
Distribution: Nationwide throughout the United States

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Drug Recall Ongoing Historical recordClass I

Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.

by Camber Pharmaceuticals Inc.

Reason: Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Recall initiated: March 13, 2023
Reported by FDA: May 17, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

by Gadget Island, Inc

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated: April 26, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass I

NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.

by Gadget Island, Inc

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated: April 26, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass I

Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.

by Gadget Island, Inc

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated: April 26, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.

by Family Dollar Stores, Llc.

Reason: CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated: March 31, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles

by Family Dollar Stores, Llc.

Reason: CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated: March 31, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets

by Family Dollar Stores, Llc.

Reason: CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated: March 31, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.

by Family Dollar Stores, Llc.

Reason: CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated: March 31, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.

by Seatex LLC

Reason: Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Recall initiated: April 19, 2023
Reported by FDA: May 10, 2023
Distribution: FL, GA, TX

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Drug Recall Terminated Historical recordClass II

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP deviations.
Recall initiated: April 6, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the US.

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Drug Recall Terminated Historical recordClass II

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP deviations.
Recall initiated: April 6, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the US.

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Drug Recall Terminated Historical recordClass II

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP deviations.
Recall initiated: April 6, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the US.

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Drug Recall Terminated Historical recordClass II

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP deviations.
Recall initiated: April 6, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the US.

View recall →

Data last updated: November 2, 2026 ET

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.