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 7761–7780 of 17,529 recalls

January 18, 2019· Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Recalled Item: Alprazolam Tablets

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardTerminated
Refund
January 18, 2019· Prinston Pharmaceutical Inc

Recalled Item: Irbesartan and Hydrochlorothiazide Tablets

The Issue: CGMP Deviations: FDA lab confirmed presence an impurity,

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

Class II — Potential Health HazardCompleted
Refund
January 18, 2019· Mylan Pharmaceuticals Inc.

Recalled Item: Fexofenadine HCl Tablets

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardTerminated
Refund
January 18, 2019· Prinston Pharmaceutical Inc

Recalled Item: Irbesartan Tablets 300 mg 90 count Rx only Manufactured by:

The Issue: CGMP Deviations: FDA lab confirmed presence an impurity,

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

Class II — Potential Health HazardCompleted
Refund
January 18, 2019· Prinston Pharmaceutical Inc

Recalled Item: Irbesartan and Hydrochlorothiazide Tablets

The Issue: CGMP Deviations: FDA lab confirmed presence an impurity,

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

Class II — Potential Health HazardCompleted
Refund
January 18, 2019· Prinston Pharmaceutical Inc

Recalled Item: Irbesartan and Hydrochlorothiazide Tablets

The Issue: CGMP Deviations: FDA lab confirmed presence an impurity,

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

Class II — Potential Health HazardCompleted
Refund
January 18, 2019· Prinston Pharmaceutical Inc

Recalled Item: Irbesartan and HydrochlorothiazideTablets

The Issue: CGMP Deviations: FDA lab confirmed presence an impurity,

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

Class II — Potential Health HazardCompleted
Refund
January 16, 2019· KRS Global Biotechnology, Inc

Recalled Item: NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF)

The Issue: Labeling: Label mix-up

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

Class II — Potential Health HazardTerminated
Refund
January 16, 2019· KRS Global Biotechnology, Inc

Recalled Item: NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF)

The Issue: Labeling: Label mix-up

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

Class II — Potential Health HazardTerminated
Refund
January 16, 2019· Rx Pak Division of McKesson Corporation

Recalled Item: Docusate Sodium

The Issue: Labeling: Label mix-up: Secondary carton may be labeled

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

Class II — Potential Health HazardTerminated
Refund
January 15, 2019· Tris Pharma Inc.

Recalled Item: infants* IBUPROFEN

The Issue: Superpotent Drug: recalled lots may have higher concentration

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

Class II — Potential Health HazardTerminated
Refund
January 15, 2019· Tris Pharma Inc.

Recalled Item: Infants' Ibuprofen

The Issue: Superpotent Drug: recalled lots may have higher concentration

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

Class II — Potential Health HazardTerminated
Refund
January 15, 2019· Tris Pharma Inc.

Recalled Item: Infants' Ibuprofen

The Issue: Superpotent Drug: recalled lots may have higher concentration

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

Class II — Potential Health HazardTerminated
Refund
January 15, 2019· LUPIN SOMERSET

Recalled Item: Fluocinolone Acetonide Topical Solution

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardTerminated
Refund
January 15, 2019· Advanced Pharma Inc.

Recalled Item: HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution

The Issue: Labeling; Label Error on Declared Strength; label incorrectly

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

Class II — Potential Health HazardTerminated
Refund
January 15, 2019· Dr. Reddy's Laboratories, Inc.

Recalled Item: Ezetimibe and Simvastatin Tablets 10mg/80 mg

The Issue: Presence of Foreign Substance: Product complaint of black

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

Class II — Potential Health HazardTerminated
Refund
January 11, 2019· Oxalis Labs

Recalled Item: Clobetasol Propionate Topical Solution USP

The Issue: Defective Container; complaints of leakage

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

Class III — Low RiskTerminated
Refund
January 10, 2019· McGuff Compounding Pharmacy Services, Inc.

Recalled Item: Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid)

The Issue: Presence of Particulate Matter: filmy/cloudy particulate observed in

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

Class II — Potential Health HazardTerminated
Refund
January 10, 2019· MAJOR PHARMACEUTICALS

Recalled Item: Losartan Potassium Tablets

The Issue: CGMP Deviations: FDA lab confirmed presence of an

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

Class II — Potential Health HazardTerminated
Refund
January 9, 2019· Lupin Pharmaceuticals Inc.

Recalled Item: Cephalexin for Oral Suspension USP 250mg/5 mL

The Issue: CGMP Deviations; presence of extraneous material in the

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

Class II — Potential Health HazardTerminated
Refund