Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 8 FDA drug recalls.

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DateProductReasonClassFirm
Apr 14, 2014 Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorph... Subpotent Drug: Phenylephrine component is subpotent. Class III P&L Developments, LLC
Apr 11, 2014 Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dex... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Feb 4, 2014 Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan ... Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenes... Class III Aaron Industries Inc
Apr 4, 2013 Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextrom... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 18, 2013 Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 18, 2013 Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextro... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 18, 2013 Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextro... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Jan 18, 2013 Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorp... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.