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Browse Drug Recalls

44 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 44 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 44 FDA drug recalls.

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DateProductReasonClassFirm
Jan 30, 2013 Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufac... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Dis... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, I... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzale... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottl... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuti... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OT... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 1... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, M... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape F... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz.... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactu... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, ... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufac... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Man... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufacture... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, ... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, M... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Ma... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongesta... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactur... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactur... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bot... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 ... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, ... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape F... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz.... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl o... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bo... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppress... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, M... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, ... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. ... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, 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.