Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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Date	Product	Reason	Class	Firm
Feb 13, 2013	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceed...	Class III	Actavis Elizabeth LLC
Feb 13, 2013	ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 ta...	Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (disp...	Class II	Watson Laboratories Inc
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 12, 2013	0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Onl...	Lack of Assurance of Sterility: There is a potential for the solution to leak from the administra...	Class II	Hospira Inc.
Feb 11, 2013	Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Man...	cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practi...	Class II	Jubilant Cadista Pharmaceuticals Inc.
Feb 8, 2013	Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Wat...	Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate ...	Class II	Watson Laboratories Inc
Feb 8, 2013	Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Wat...	Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate ...	Class II	Watson Laboratories Inc
Feb 7, 2013	CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blist...	Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specificat...	Class II	Teva Pharmaceuticals USA, Inc.
Feb 6, 2013	Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured fo...	Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg...	Class II	West-ward Pharmaceutical Corp.
Feb 4, 2013	buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto...	Failed Stability Specifications; out of specification results at the 9 month stability time point...	Class III	American Health Packaging
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.
Feb 1, 2013	CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, R...	Labeling: Missing label	Class III	Fresenius Kabi USA LLC (FK USA)
Feb 1, 2013	TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti...	Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre...	Class III	Ferring Pharmaceuticals Inc
Jan 31, 2013	Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when r...	Discoloration; Product may not meet specifications for color description once reconstituted.	Class III	Lupin Pharmaceuticals Inc.
Jan 31, 2013	Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx on...	Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir ...	Class I	Gilead Sciences, 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	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.
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	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	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	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	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	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	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	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 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	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	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	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	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	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 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	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	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	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	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	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	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	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	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	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	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	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	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	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	Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bot...	Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may ...	Class II	Mylan Pharmaceuticals 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	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	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 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.

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.