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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 101–120 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

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Drug Recall Ongoing 2026 recordClass II

Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass II

Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.

by Baxter Healthcare Corporation

Reason
CGMP Deviations
Recall initiated
August 6, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide; Puerto Rico; and Chile.

View recall →

Drug Recall Ongoing 2026 recordClass I

Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00

by B BRAUN MEDICAL INC

Reason
Presence of Particulate matter.
Recall initiated
August 12, 2026
Reported by FDA
September 2, 2026
Distribution
U.S. Nationwide

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Drug Recall Ongoing 2026 recordClass II

Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.

by Hikma Pharmaceuticals USA Inc.

Reason
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Recall initiated
August 24, 2026
Reported by FDA
September 2, 2026
Distribution
Nationwide within the United States

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Drug Recall Ongoing 2026 recordClass I

Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.

by Fresenius Kabi USA, LLC

Reason
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Recall initiated
August 10, 2026
Reported by FDA
September 2, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Paxil CR, 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 60505-4379-3

by Apotex Corp.

Reason
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Recall initiated
August 13, 2026
Reported by FDA
September 2, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2

by Mallinckrodt Hospital Products Inc.

Reason
Presence of particulate matter: glass and stopper piece
Recall initiated
August 6, 2026
Reported by FDA
September 2, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.

by Church & Dwight Co., Inc.

Reason
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Recall initiated
August 10, 2026
Reported by FDA
September 2, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.

by Lupin Pharmaceuticals Inc.

Reason
Failed content uniformity specifications.
Recall initiated
August 3, 2026
Reported by FDA
September 2, 2026
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug
Recall initiated
August 6, 2026
Reported by FDA
September 2, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug
Recall initiated
August 6, 2026
Reported by FDA
September 2, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.

by ACCORD HEALTHCARE, INC.

Reason
Subpotent Drug
Recall initiated
August 6, 2026
Reported by FDA
September 2, 2026
Distribution
Nationwide within the United States

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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