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  1. Drug Safety and Availability

Drug Recalls

A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.

The list below includes voluntary recalls in which public notification has been issued.

See FDA’s role in drug recalls for more information.
See Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
For recall notices older than 60 days, see recall and safety alerts archive.

Resources for You

A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

Date Brand Name(s) Product Description Recall Reason Description Company Name Terminated Recall Excerpt
G-SUPRESS DX Cough Suppressant, expectorant, nasal decongestant pediatric drops Packaging may contain incorrect product NOVIS PR LLC
G-SUPRESS DX Cough Suppressant, expectorant, nasal decongestant pediatric drops Device & Drug Safety/Mislabeling NOVIS PR LLC
Numerous Brands Various human and animal drug products As a result of a bankruptcy, the firm is removing several products from the market due to the discontinuation of the Quality program which would result in the company’s inability to assure that products meet the identity, strength, quality, and purity cha Akorn Operating Company LLC
Advil Over-The-Counter Drugs Product was stored outside of labeled temperature requirements. Family Dollar
Mayne Pharma Inc. FENTANYL Buccal Tablets CII Safety updates were omitted in the Product Insert/Medication Guide (MG) Teva Pharmaceuticals USA
Pro Power Knight Plus, NUX, Dynamite Super Male enhancement capsules Product contains undeclared tadalafil and sildenafil Gadget Island, Inc.
Camber Atovaquone Oral Suspension Potential Bacillus cereus Contamination Camber Pharmaceuticals, Inc.
Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution Due to Presence of Methanol Jarman’s Midwest Cleaning Systems, Inc.
Ascend Laboratories Dabigatran Etexilate Capsules, USP Detection of N-nitroso-dabigatran (NDAB) Impurity Ascend Laboratories LLC.
Purely Soothing 15% MSM Drops Non-sterility Pharmedica USA LLC
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