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 4501–4520 of 17,529 recalls

August 13, 2021· First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Recalled Item: LEVOCARNITINE 100MG/ML MDV SOLN

The Issue: Lack of Assurance of Sterility: FDA inspection raised

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

Class II — Potential Health HazardTerminated
Refund
August 13, 2021· First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Recalled Item: MIC/B12A 25/50/50MG/ML 1MG/ML MDV

The Issue: Lack of Assurance of Sterility: FDA inspection raised

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

Class II — Potential Health HazardTerminated
Refund
August 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 0.5mg

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above

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

Class II — Potential Health HazardOngoing
Refund
August 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 1 mg

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above

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

Class II — Potential Health HazardOngoing
Refund
August 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 0.5mg/1mg

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above

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

Class II — Potential Health HazardOngoing
Refund
August 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 1 mg

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above

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

Class II — Potential Health HazardOngoing
Refund
August 13, 2021· Akorn, Inc.

Recalled Item: Betamethasone Dipropionate Lotion USP (Augmented)

The Issue: Failed impurities/degradation specification: Out of Specification for an

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

Class II — Potential Health HazardTerminated
Refund
August 13, 2021· SigmaPharm Laboratories LLC

Recalled Item: Sodium Phenylbutyrate POWDER

The Issue: Failed Impurities Specifications: Out of Specification impurity results

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

Class II — Potential Health HazardTerminated
Refund
August 13, 2021· Zydus Pharmaceuticals (USA) Inc

Recalled Item: Carvedilol Tablets

The Issue: Presence of Foreign Tablets/Capsules; report of two Paroxetine

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

Class II — Potential Health HazardTerminated
Refund
August 12, 2021· ANHUI WELCOME FOREIGN TRADE CO.,LTD.

Recalled Item: Pi yen chin Ophthalmic Redness Reliever Drops Made in China

The Issue: Labeling: Not Elsewhere Classified; The packaging states these

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

Class II — Potential Health HazardTerminated
Refund
August 11, 2021· Ebay Seller - John Nguyen

Recalled Item: Hydro Pinapple Burn Max Health Thach Dua

The Issue: Undeclared Sibutramine

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

Class I — Serious Health HazardTerminated
Refund
August 11, 2021· Granules USA, Inc.

Recalled Item: Naproxen Sodum Tablets USP 220 mg

The Issue: CGMP Deviations

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

Class II — Potential Health HazardTerminated
Refund
August 10, 2021· SterRx, LLC

Recalled Item: Sodium Bicarbonate in 5% Dextrose Injection

The Issue: Non-Sterility: firm's third party lab confirmed microbial contamination

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

Class I — Serious Health HazardTerminated
Refund
August 10, 2021· SterRx, LLC

Recalled Item: Sodium Bicarbonate in 5% Dextrose Injection

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
August 6, 2021· The Harvard Drug Group

Recalled Item: Carbamazepine 200mg Tablets

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardTerminated
Refund
August 6, 2021· XELLIA PHARMACEUTICALS USA, LLC

Recalled Item: Micafungin for Injection

The Issue: Labeling; Incorrect or Missing Package Insert: The package

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

Class II — Potential Health HazardTerminated
Refund
August 6, 2021· XELLIA PHARMACEUTICALS USA, LLC

Recalled Item: Micafungin for Injection

The Issue: Labeling; Incorrect or Missing Package Insert: The package

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

Class II — Potential Health HazardTerminated
Refund
August 5, 2021· Hikma Pharmaceuticals USA Inc.

Recalled Item: Bleomycin for Injection

The Issue: Mislabeling

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

Class III — Low RiskTerminated
Refund
August 5, 2021· DuPont Nutrition USA, Inc

Recalled Item: Avicel

The Issue: Out of specification results for conductivity

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

Class III — Low RiskTerminated
Refund
August 3, 2021· The Harvard Drug Group

Recalled Item: Fexofenadine Hydrochloride Tablets

The Issue: Failed Quality Specifications

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

Class II — Potential Health HazardTerminated
Refund