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 1221–1240 of 17,529 recalls

May 6, 2024· Rubicon Research Private Limited

Recalled Item: Metoprolol Tartrate Tablets USP

The Issue: Presence of Foreign Substance: metal in tablet

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

Class II — Potential Health HazardOngoing
Refund
May 2, 2024· RemedyRepack Inc.

Recalled Item: TraMADol HCl 50 mg Tablet

The Issue: Presence of Foreign Tablets: Manufacturer received a report

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

Class II — Potential Health HazardTerminated
Refund
May 1, 2024· Dr. Reddy's Laboratories, Inc.

Recalled Item: Sirolimus Tablets 1mg Tablets 100-count bottle

The Issue: Failed Quality Specifications

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

Class III — Low RiskOngoing
Refund
May 1, 2024· Pharma Nobis LLC

Recalled Item: Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free

The Issue: Microbial Contamination of Non-Sterile Products - Presence of

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

Class II — Potential Health HazardOngoing
Refund
May 1, 2024· Pharma Nobis LLC

Recalled Item: CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE

The Issue: Microbial Contamination of Non-Sterile Products - Presence of

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

Class II — Potential Health HazardOngoing
Refund
April 30, 2024· Viatris Inc

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

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardCompleted
Refund
April 30, 2024· Viatris Inc

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

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardCompleted
Refund
April 30, 2024· Hikma Injectables USA Inc

Recalled Item: Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection

The Issue: Labeling: Wrong Barcode

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

Class III — Low RiskCompleted
Refund
April 29, 2024· Hikma Injectables USA Inc

Recalled Item: Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free

The Issue: Mislabeling

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

Class I — Serious Health HazardCompleted
Refund
April 29, 2024· Breckenridge Pharmaceutical, Inc

Recalled Item: Duloxetine Delayed-Release Capsules

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

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

Class II — Potential Health HazardOngoing
Refund
April 29, 2024· Breckenridge Pharmaceutical, Inc

Recalled Item: Duloxetine Delayed-Release Capsules

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

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

Class II — Potential Health HazardOngoing
Refund
April 29, 2024· Breckenridge Pharmaceutical, Inc

Recalled Item: Duloxetine Delayed-Release Capsules

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

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

Class II — Potential Health HazardOngoing
Refund
April 26, 2024· Rubicon Research Private Limited

Recalled Item: traMADol Hydrochloride Tablets

The Issue: Presence of Foreign Tablets: Pharmacist reported a tablet

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

Class II — Potential Health HazardOngoing
Refund
April 25, 2024· Sagent Pharmaceuticals

Recalled Item: MethylPREDNISolone Acetate Injectable Suspension

The Issue: Presence of Particulate Matter: Potential for black particulates

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

Class II — Potential Health HazardOngoing
Refund
April 25, 2024· FDC Limited

Recalled Item: Timolol Maleate Ophthalmic Solution

The Issue: Defective Container: yellow-colored spike from cap lodged in

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

Class II — Potential Health HazardCompleted
Refund
April 25, 2024· Viatris Inc

Recalled Item: Valacyclovir Tablets USP

The Issue: Failed Quality Specifications

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

Class III — Low RiskCompleted
Refund
April 24, 2024· Coast Quality Pharmacy, LLC dba Anazao Health

Recalled Item: Progesterone 200 mg

The Issue: Presence of Foreign Substance; Broken metal piece found

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

Class II — Potential Health HazardCompleted
Refund
April 24, 2024· SOMERSET THERAPEUTICS LLC

Recalled Item: Haloperidol decanoate Injection 50mg/mL

The Issue: Presence of Foreign Substance: This oil based product

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

Class II — Potential Health HazardOngoing
Refund
April 24, 2024· Lupin Pharmaceuticals Inc.

Recalled Item: Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted)

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
Refund
April 24, 2024· Lupin Pharmaceuticals Inc.

Recalled Item: Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted)

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
Refund