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 4381–4400 of 17,529 recalls

September 17, 2021· Fresenius Kabi USA LLC

Recalled Item: Morphine Sulfate Injection

The Issue: Defective container: Cracked vials leading to lack of

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

Class II — Potential Health HazardTerminated
Refund
September 17, 2021· IntegraDose Compounding Services LLC

Recalled Item: ceFAZolin 3 G in 0.9% Sodium Chloride

The Issue: Lack of sterility assurance

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

Class II — Potential Health HazardTerminated
Refund
September 15, 2021· American Health Packaging

Recalled Item: Valproic Acid Oral Solution

The Issue: CGMP Deviations: Potential concern with products manufactured using

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

Class II — Potential Health HazardTerminated
Refund
September 14, 2021· Direct Rx

Recalled Item: Zonisamide 100 mg Capsules

The Issue: CGMP deviations: Gaps in the quality system in

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

Class II — Potential Health HazardTerminated
Refund
September 13, 2021· Viatris

Recalled Item: Candesartan Cilexetil Tablets

The Issue: Failed Quality Specifications

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

Class III — Low RiskTerminated
Refund
September 10, 2021· Piramal Critical Care, Inc.

Recalled Item: Rocuronium Bromide Injection 50mg/5 mL

The Issue: Labeling: Label Lacks Warning or Rx Legend: Finished

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

Class II — Potential Health HazardTerminated
Refund
September 9, 2021· Jacobus Pharmaceutical Company Inc.

Recalled Item: Ruzurgi (amifampridine) Tablets 10 mg

The Issue: Microbial contamination of non-sterile products: Firm's testing found

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

Class I — Serious Health HazardTerminated
Refund
September 9, 2021· Aurobindo Pharma USA Inc.

Recalled Item: Metoprolol Tartrate Tablets USP 100 mg

The Issue: Presence of Foreign Substance: Product complaints received for

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

Class II — Potential Health HazardTerminated
Refund
September 9, 2021· Vi-Jon, Inc.

Recalled Item: Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ

The Issue: Labeling: Label Mix-Up.The recall has been initiated after

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

Class II — Potential Health HazardTerminated
Refund
September 8, 2021· Akorn, Inc.

Recalled Item: TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
September 3, 2021· Morton Grove Pharmaceuticals, Inc.

Recalled Item: Promethazine With Codeine Oral Solution

The Issue: CGMP Deviations: Potential concern with products manufactured using

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

Class II — Potential Health HazardCompleted
Refund
September 3, 2021· Morton Grove Pharmaceuticals, Inc.

Recalled Item: Valproic Acid Oral Solution USP

The Issue: CGMP Deviations: Potential concern with products manufactured using

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

Class II — Potential Health HazardCompleted
Refund
September 3, 2021· Morton Grove Pharmaceuticals, Inc.

Recalled Item: Promethazine Syrup Plain

The Issue: CGMP Deviations: Potential concern with products manufactured using

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

Class II — Potential Health HazardCompleted
Refund
September 3, 2021· ICU Medical Inc

Recalled Item: AMINOSYN II 15% An Amino Acid Injection

The Issue: Presence of Particulate Matter: Particulate matter identified as

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

Class I — Serious Health HazardTerminated
Refund
September 3, 2021· Meitheal Pharmaceuticals Inc

Recalled Item: Glycopyrrolate Injection

The Issue: Failed Quality Specifications

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

Class III — Low RiskTerminated
Refund
September 2, 2021· RISING PHARMACEUTICALS

Recalled Item: Meclizine HCl Tablets

The Issue: Labeling: Incorrect Instructions

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

Class II — Potential Health HazardOngoing
Refund
September 2, 2021· New Vision Pharmaceuticals LLC

Recalled Item: CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials

The Issue: Subpotent Drug

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

Class III — Low RiskTerminated
Refund
September 2, 2021· New Vision Pharmaceuticals LLC

Recalled Item: Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51

The Issue: Subpotent Drug

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

Class III — Low RiskTerminated
Refund
September 1, 2021· Monarch PCM, LLC

Recalled Item: Hydroquinone

The Issue: Subpotency: one product for active ingredient assay and

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

Class III — Low RiskTerminated
Refund
September 1, 2021· Monarch PCM, LLC

Recalled Item: Sodium Sulfacetamide

The Issue: Subpotency: one product for active ingredient assay and

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

Class III — Low RiskTerminated
Refund