Browse Drug Recalls

6,228 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,228 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 6,228 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jul 2, 2019	CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), It...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 ...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservat...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M ...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Ster...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 m...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), ...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 687...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 1...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pha...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, M...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manu...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Pa...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Sing...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 4953...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), ...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufac...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jul 2, 2019	iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile...	Lack of Assurance of Sterility	Class II	Altaire Pharmaceuticals, Inc.
Jun 26, 2019	Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, F...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pha...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only,...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First P...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx on...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma ...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma As...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 m...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, Firs...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, ...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, ...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Assoc...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Phar...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)1...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019	Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associat...	Lack of Assurance of Sterility.	Class II	First Pharma Associates LLC dba Riverpoint Phar...
Jun 19, 2019	PROCAINE HCL (PFV) 20 MG/ML INJECTABLE SOLUTION, 30 ML per vial, RXQ Compound...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compou...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 3...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compo...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compoun...	Lack of Assurance of Sterility	Class II	RXQ Compounding 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.