Browse Drug Recalls

1,528 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,528 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 1,528 FDA drug recalls in FL.

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Date	Product	Reason	Class	Firm
Mar 22, 2013	buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablet...	Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour ...	Class III	Actavis South Atlantic LLC
Mar 22, 2013	Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-cou...	Failed Tablet/Capsule Specifications: Broken tablets	Class II	Watson Laboratories, Inc.-(Actavis) - Florida
Mar 18, 2013	Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ...	Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec...	Class I	Apotex Corp.
Mar 16, 2013	"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simeth...	Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count ...	Class II	Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
Feb 12, 2013	MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 c...	Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA dr...	Class I	OLAAX International
Feb 4, 2013	Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonat...	CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was no...	Class II	Carib Import & Export, Inc.
Jan 31, 2013	Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 ho...	Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re...	Class II	Noven Pharmaceuticals, Inc.
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.

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.