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
1 this month

Showing 5081–5100 of 17,529 recalls

January 11, 2021· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Testosterone Cypionate Injection

The Issue: Incorrect Labeling: Incorrect lot number on secondary packaging

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

Class III — Low RiskTerminated
Refund
January 8, 2021· Taro Pharmaceuticals U.S.A., Inc.

Recalled Item: Nortriptyline HCl Capsules

The Issue: CGMP deviations

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

Class II — Potential Health HazardTerminated
Refund
January 7, 2021· Bausch Health Companies, Inc.

Recalled Item: Phytonadione Tablets 5mg

The Issue: Failed Quality Specifications

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

Class III — Low RiskTerminated
Refund
January 7, 2021· Bausch Health Companies, Inc.

Recalled Item: Mephyton (phytonadione) Tablets 5mg

The Issue: Failed Quality Specifications

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

Class III — Low RiskTerminated
Refund
January 7, 2021· American Health Packaging

Recalled Item: Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals)

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardTerminated
Refund
January 6, 2021· DLC Laboratories, Inc

Recalled Item: Sulfur Ointment 10%

The Issue: Labeling: Label Mix-Up. THe English label with Drug

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

Class II — Potential Health HazardTerminated
Refund
January 4, 2021· Nostrum Laboratories Inc

Recalled Item: Metformin Hydrochloride Extended-Release Tablets

The Issue: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above

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

Class II — Potential Health HazardOngoing
Refund
January 1, 2021· Precision Dose Inc.

Recalled Item: Chlorhexidine Gluconate Oral Rinse USP 0.12%

The Issue: cGMP deviations: The firm was notified of the

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

Class II — Potential Health HazardTerminated
Refund
December 30, 2020· AuroMedics Pharma LLC

Recalled Item: Acetaminophen Injection 1

The Issue: Discoloration and failed pH specifications

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

Class II — Potential Health HazardTerminated
Refund
December 30, 2020· Allergan, PLC.

Recalled Item: Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz

The Issue: Labeling: Missing instructions for use insert

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

Class II — Potential Health HazardTerminated
Refund
December 28, 2020· Sunstar Americas, Inc.

Recalled Item: Paroex (Chlorhexidine Gluconate) Oral Rinse

The Issue: cGMP Deviations; FDA inspection of manufacturing facility observed

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

Class II — Potential Health HazardOngoing
Refund
December 28, 2020· Akorn, Inc.

Recalled Item: Levetiracetam Oral Solution

The Issue: Defective container: Customer complaints for oral solution leaking

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

Class II — Potential Health HazardTerminated
Refund
December 23, 2020· Shane Erickson Inc

Recalled Item: IMC Wash-Free Hand Sanitizer

The Issue: CGMP Deviations: product manufactured at the same facility

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

Class II — Potential Health HazardTerminated
Refund
December 23, 2020· Shane Erickson Inc

Recalled Item: IMC Wash-Free Hand Sanitizer

The Issue: CGMP Deviations: product manufactured at the same facility

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

Class II — Potential Health HazardTerminated
Refund
December 23, 2020· Shane Erickson Inc

Recalled Item: IMC Wash-Free Hand Sanitizer

The Issue: CGMP Deviations: product manufactured at the same facility

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

Class II — Potential Health HazardTerminated
Refund
December 23, 2020· Fresenius Kabi USA, LLC

Recalled Item: Ketorolac Tromethamine Injection

The Issue: Presence of Particulate Matter - found in reserve

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

Class I — Serious Health HazardTerminated
Refund
December 23, 2020· Genus Lifesciences Inc.

Recalled Item: Oxycodone Hydrochloride Oral Solution

The Issue: Presence of Foreign Substance: Particulate matter was found

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

Class III — Low RiskTerminated
Refund
December 22, 2020· Edge Pharma, LLC

Recalled Item: Epinephrine/Lidocaine HCl

The Issue: Labeling: Incorrect or Missing Lot and/or Exp Date

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

Class III — Low RiskTerminated
Refund
December 22, 2020· Strides Pharma Inc.

Recalled Item: NDC 64380-721-06 TACROLIMUS CAPSULES

The Issue: Failed Moisture Limits

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

Class III — Low RiskTerminated
Refund
December 21, 2020· Merck Sharp & Dohme

Recalled Item: Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection

The Issue: Lack of assurance of sterility: The results of

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

Class II — Potential Health HazardTerminated
Refund