Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

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Date	Product	Reason	Class	Firm
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	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	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	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	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	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	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	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 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	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	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	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	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	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 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	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 25, 2019	Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U...	Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da...	Class III	AAA Pharmaceutical, Inc.
Jun 24, 2019	Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by To...	Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi...	Class II	H J Harkins Company Inc dba Pharma Pac
Jun 24, 2019	Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torren...	Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi...	Class II	H J Harkins Company Inc dba Pharma Pac
Jun 21, 2019	GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Pheny...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain ...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manu...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufacture...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnic...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin),...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.1...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical ...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 21, 2019	ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7...	CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,...	Class II	Pharma-Natural Inc.
Jun 20, 2019	Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for:...	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ...	Class II	Macleods Pharma Usa Inc
Jun 20, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tabl...	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ...	Class II	Macleods Pharma Usa Inc
Jun 20, 2019	Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Ma...	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ...	Class II	Macleods Pharma Usa Inc
Jun 20, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tab...	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ...	Class II	Macleods Pharma Usa Inc
Jun 20, 2019	Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, US...	CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ...	Class II	Macleods Pharma Usa Inc
Jun 19, 2019	GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 3...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State ...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compou...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89;...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding,...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Str...	Lack of Assurance of Sterility	Class II	RXQ Compounding LLC
Jun 19, 2019	FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (...	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.