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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 81–100 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.

by MYLAN PHARMACEUTICALS INC

Reason
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Recall initiated
August 17, 2026
Reported by FDA
September 9, 2026
Distribution
Nationwide within the U.S

View recall →

Drug Recall Ongoing 2026 recordClass III

Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01

by Chiesi USA, Inc.

Reason
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Recall initiated
August 19, 2026
Reported by FDA
September 9, 2026
Distribution
MO, TN

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Drug Recall Ongoing 2026 recordClass II

2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26

by Sage Products, LLC

Reason
Cross Contamination with Other Products
Recall initiated
August 18, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01

by Teva Pharmaceuticals USA, Inc

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
August 24, 2026
Reported by FDA
September 9, 2026
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass III

Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.

by Supernus Pharmaceuticals, Inc.

Reason
Failed dissolution specifications.
Recall initiated
August 31, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.

by MYLAN PHARMACEUTICALS INC

Reason
Failed Dissolution Specifications
Recall initiated
August 26, 2026
Reported by FDA
September 9, 2026
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4

by Lexia LLC

Reason
CGMP Deviations: Potential contamination of raw material
Recall initiated
August 21, 2026
Reported by FDA
September 9, 2026
Distribution
Distributed in the state of Colorado (US).

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Drug Recall Ongoing 2026 recordClass II

Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7

by Lexia LLC

Reason
CGMP Deviations: Potential contamination of raw material
Recall initiated
August 21, 2026
Reported by FDA
September 9, 2026
Distribution
Distributed in the state of Colorado (US).

View recall →

Drug Recall Ongoing 2026 recordClass II

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853

by Allies Group Inc.

Reason
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Recall initiated
August 14, 2026
Reported by FDA
September 9, 2026
Distribution
Nationwide within the U.S.A

View recall →

Drug Recall Ongoing 2026 recordClass II

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733

by Allies Group Inc.

Reason
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Recall initiated
August 14, 2026
Reported by FDA
September 9, 2026
Distribution
Nationwide within the U.S.A

View recall →

Drug Recall Ongoing 2026 recordClass II

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293

by Allies Group Inc.

Reason
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Recall initiated
August 14, 2026
Reported by FDA
September 9, 2026
Distribution
Nationwide within the U.S.A

View recall →

Drug Recall Ongoing 2026 recordClass II

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224

by Allies Group Inc.

Reason
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Recall initiated
August 14, 2026
Reported by FDA
September 9, 2026
Distribution
Nationwide within the U.S.A

View recall →

Drug Recall Ongoing 2026 recordClass III

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.

by Bionpharma Inc.

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
August 7, 2026
Reported by FDA
September 9, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.

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 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.

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, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.

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

Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.

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

Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50.

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

Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.

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

Clindamycin Injection USP in 5% Dextrose, 900 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 0338-3814-50.

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 →

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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