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 6001–6020 of 17,529 recalls

January 14, 2020· Spectrum Laboratory Products

Recalled Item: Ranitidine Hydrochloride (powder)

The Issue: CGMP Deviations: Presence of NDMA impurity detected in

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

Class II — Potential Health HazardTerminated
Refund
January 14, 2020· Pharmaceutical Associates Inc

Recalled Item: Nystatin Oral Suspension

The Issue: Subpotent: Out of specification for assay at the

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

Class II — Potential Health HazardTerminated
Refund
January 14, 2020· Hikma Pharmaceuticals USA Inc.

Recalled Item: methylPREDNISolone Sodium Succinate For Injection

The Issue: Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare

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

Class III — Low RiskTerminated
Refund
January 14, 2020· Sun Pharmaceutical Industries, Inc.

Recalled Item: Testosterone Cypionate for Injection

The Issue: cGMP Deviations; released lots were manufactured under similar

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

Class II — Potential Health HazardTerminated
Refund
January 14, 2020· Sun Pharmaceutical Industries, Inc.

Recalled Item: Testosterone Cypionate for Injection

The Issue: cGMP Deviations; released lots were manufactured under similar

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

Class II — Potential Health HazardTerminated
Refund
January 10, 2020· PD-Rx Pharmaceuticals, Inc.

Recalled Item: ranitidine hydrochloride

The Issue: CGMP Deviations: Received notice from supplier of potential

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

Class II — Potential Health HazardTerminated
Refund
January 10, 2020· Advanced Accelerator Applications USA, Inc.

Recalled Item: NETSPOT

The Issue: Defective Container: loose aluminum cap crimp for the

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

Class II — Potential Health HazardTerminated
Refund
January 10, 2020· Letco Medical LLC

Recalled Item: Estriol USP Micronized a) 100 gm NDC 62991-2159-04

The Issue: Subpotent

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

Class II — Potential Health HazardTerminated
Refund
January 10, 2020· Lupin Pharmaceuticals Inc.

Recalled Item: Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets

The Issue: CGMP Deviations: Out of specification test result observed

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

Class III — Low RiskTerminated
Refund
January 7, 2020· Sigan Industries Inc.

Recalled Item: Eczema Skin Relief Lotion

The Issue: Microbial contamination of non-sterile product

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

Class III — Low RiskTerminated
Refund
January 7, 2020· Mylan Pharmaceuticals Inc.

Recalled Item: Nizatidine Capsules

The Issue: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine

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

Class II — Potential Health HazardTerminated
Refund
January 7, 2020· Mylan Pharmaceuticals Inc.

Recalled Item: Nizatidine Capsules

The Issue: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine

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

Class II — Potential Health HazardTerminated
Refund
January 7, 2020· Preferred Pharmaceuticals, Inc

Recalled Item: Preferred Pharmaceuticals

The Issue: CGMP Deviations: Presence of NDMA impurity detected in

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

Class II — Potential Health HazardTerminated
Refund
January 7, 2020· Preferred Pharmaceuticals, Inc

Recalled Item: Preferred Pharmaceuticals

The Issue: CGMP Deviations: Presence of NDMA impurity detected in

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

Class II — Potential Health HazardTerminated
Refund
January 7, 2020· AVKARE Inc.

Recalled Item: Dutasteride Capsules

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardTerminated
Refund
January 7, 2020· Appco Pharma LLC

Recalled Item: Ranitidine Capsules 300 mg

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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

Class II — Potential Health HazardTerminated
Refund
January 7, 2020· Appco Pharma LLC

Recalled Item: Ranitidine Capsules 150 mg

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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

Class II — Potential Health HazardTerminated
Refund
January 6, 2020· H J Harkins Company Inc dba Pharma Pac

Recalled Item: Ranitidine

The Issue: CGMP Deviations: Presence of NDMA impurity detected in

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

Class II — Potential Health HazardTerminated
Refund
December 27, 2019· RemedyRepack Inc.

Recalled Item: Ketorolac Trom

The Issue: Presence of Particulate Matter: Medication relabeled at facility

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

Class I — Serious Health HazardTerminated
Refund
December 26, 2019· Akorn, Inc.

Recalled Item: Proparacaine Hydrochloride Ophthalmic Solution

The Issue: Chemical contamination; out of specification results obtained for

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

Class III — Low RiskTerminated
Refund