Drug Recalls

Here you'll find every drug recall the FDA has issued, including prescription medications, over-the-counter drugs, compounded pharmacy products, and dietary supplements. We've been tracking these since 2006 and our database updates several times a day so you're always looking at current information.

Drugs get recalled for a number of reasons: contamination during manufacturing, incorrect potency or dosage, failed quality testing (like dissolution or stability tests), sterility problems in injectable products, or labeling and packaging errors that could cause someone to take the wrong dose. If you find a product on this list that you use, please follow the instructions provided by the FDA to take the necessary precautions.

17,529 total recalls
2 this month

Showing 861–880 of 17,529 recalls

January 13, 2025· The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Recalled Item: Duloxetine Delayed-Release Capsules USP

The Issue: CGMP Deviations: presence of Nitrosamine Drug Substances Related

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
January 10, 2025· Teva Pharmaceuticals USA, Inc

Recalled Item: Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL

The Issue: Failed Stability Specifications - 12-month stability test result

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
January 8, 2025· Johnson, S C and Son, Inc

Recalled Item: babyganics

The Issue: Failed stability specifications: during routine stability monitoring quality

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
January 7, 2025· PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Recalled Item: Guaifenesin and Codeine Phosphate Oral Solution USP

The Issue: Superpotent; sodium benzoate preservative

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskCompleted
Refund
January 7, 2025· Amerisource Health Services LLC

Recalled Item: Clobazam Tablets

The Issue: Presence of Foreign Tablets/Capsules

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 30, 2024· Rising Pharma Holding, Inc.

Recalled Item: Duloxetine Delayed-Release Capsules USP 30 mg

The Issue: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 30, 2024· Rising Pharma Holding, Inc.

Recalled Item: Duloxetine DR Capsules USP 60 mg

The Issue: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 30, 2024· Granules Pharmaceuticals Inc.

Recalled Item: Metformin Hydrochloride Extended-Release Tablets

The Issue: Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 30, 2024· Rising Pharma Holding, Inc.

Recalled Item: Duloxetine Delayed-Release Capsules USP 20 mg

The Issue: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 27, 2024· Eugia US LLC

Recalled Item: Progesterone Injection USP

The Issue: Presence of Particulate Matter: A market complaint was

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 23, 2024· Astellas Pharma US Inc.

Recalled Item: Prograf (tacrolimus) capsules

The Issue: Failed Quality Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
December 23, 2024· Astellas Pharma US Inc.

Recalled Item: Astagraf XL (tacrolimus extended-release capsules) 0.5 mg

The Issue: Failed Quality Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
December 23, 2024· First Aid Beauty Ltd

Recalled Item: First Aid Beauty Ultra Repair Cream

The Issue: CGMP Deviations; product intended for quarantine was inadvertently

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
December 23, 2024· Viatris Inc

Recalled Item: Cardura XL (doxazosin) extended release tablets 8 mg

The Issue: Failed Quality Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 23, 2024· Viatris Inc

Recalled Item: Cardura XL (doxazosin) extended release tablets 4 mg

The Issue: Failed Quality Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 20, 2024· ENDO USA, Inc.

Recalled Item: Adrenalin Chloride Solution (Epinephrine Nasal Solution

The Issue: Labeling: Not Elsewhere Classified: misleading label similar in

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
December 20, 2024· Lupin Pharmaceuticals Inc.

Recalled Item: Levothyroxine Sodium Tablets

The Issue: Failed Quality Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 19, 2024· West-Ward Columbus Inc

Recalled Item: Methadone Hydrochloride Tablets

The Issue: Failed Quality Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
December 19, 2024· Hikma Injectables USA Inc

Recalled Item: ketamine inj 50 mg per 1 mL

The Issue: Lack of Assurance of Sterility: The tamper-evident seal

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund
December 19, 2024· Hikma Injectables USA Inc

Recalled Item: phenylephrine in 0.9% Sodium Chloride Inj

The Issue: Lack of Assurance of Sterility: The tamper-evident seal

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardTerminated
Refund