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.

Clear

Date	Product	Reason	Class	Firm
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 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	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	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	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	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	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	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	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	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	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 28, 2013	Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp....	Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled wit...	Class III	Stat Rx USA
Jan 25, 2013	Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container,...	Non-Sterility: Confirmed customer complaint of product contaminated with mold.	Class I	Hospira Inc.
Jan 23, 2013	Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC...	Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in...	Class II	Teva Pharmaceuticals USA, Inc.
Jan 23, 2013	Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manuf...	Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect ...	Class III	Mission Pharmacal Co
Jan 23, 2013	Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz)...	Cross Contamination with Other Products: Product was mixed with another type of mouth wash.	Class III	Procter & Gamble Hair Care Llc
Jan 22, 2013	Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg...	CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturin...	Class II	RX South LLC DBA RX3 Pharmacy
Jan 22, 2013	IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose V...	Crystallization: Active pharmaceutical ingredient is precipitating in product solution.	Class II	Fresenius Kabi USA LLC (FK USA)
Jan 22, 2013	Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blist...	Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debo...	Class III	Sandoz Incorporated
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
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	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	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 17, 2013	Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and reli...	Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminat...	Class II	Humco Holding Group, Inc
Jan 16, 2013	Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use ...	Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.	Class III	Actelion Pharmaceuticals U.S., Inc.
Jan 16, 2013	Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Myla...	Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet ...	Class II	Mylan Pharmaceuticals Inc.
Jan 11, 2013	PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Sus...	Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.	Class III	AstraZeneca LP
Jan 11, 2013	PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampul...	Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.	Class III	AstraZeneca LP
Jan 10, 2013	Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hosp...	Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial	Class II	Hospira, Inc.
Jan 8, 2013	0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 6...	Lack of Assurance of Sterility: There is the potential for solution to leak from the administrati...	Class II	Hospira Inc.
Jan 7, 2013	Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactu...	Subpotent Drug	Class III	West-ward Pharmaceutical Corp.
Jan 7, 2013	Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, U...	Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.	Class II	West-ward Pharmaceutical Corp.
Jan 4, 2013	buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bot...	Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.	Class III	Actavis Pharmaceuticals
Jan 4, 2013	Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA,...	Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingre...	Class I	Reumofan Plus USA
Jan 3, 2013	Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49...	Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.	Class I	Mobius Therapeutics LLC

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.