Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

Date	Product	Reason	Class	Firm
Dec 29, 2016	Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : ...	Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of p...	Class III	Hetero Drugs Ltd. - Unit 1
Dec 28, 2016	Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 28, 2016	Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only,...	Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of...	Class II	L. Perrigo Company
Dec 28, 2016	Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 28, 2016	Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 28, 2016	Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 27, 2016	Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by ...	Superpotent Drug; out of specification results for assay (manufacturer)	Class III	The Harvard Drug Group
Dec 22, 2016	Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratori...	Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.	Class II	Roxane Laboratories, Inc.
Dec 22, 2016	TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for:...	Failed Stability Specifications	Class III	Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Dec 22, 2016	Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactu...	Failed dissolution specification: recalled due to an out of specification dissolution result of 4...	Class II	Sandoz Incorporated
Dec 22, 2016	Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottle...	Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted caps...	Class II	Aurobindo Pharma USA Inc
Dec 21, 2016	Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo...	Subpotency: due to a low, out of specification test result for assay during stability testing.	Class II	Teva Pharmaceuticals USA
Dec 20, 2016	Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-...	Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin...	Class II	Mylan LLC.
Dec 20, 2016	Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-...	Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin...	Class II	Mylan LLC.
Dec 20, 2016	buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ...	Failed Dissolution Specifications; 18 month stability time point	Class III	Sun Pharmaceutical Industries, Inc.
Dec 20, 2016	Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord...	Failed tablet/capsule specification: missing break line on the 5mg tablet.	Class II	Accord Healthcare, Inc.
Dec 20, 2016	buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND...	Failed Dissolution Specifications; 18 month stability time point	Class III	Sun Pharmaceutical Industries, Inc.
Dec 20, 2016	Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceutical...	Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin...	Class II	Mylan LLC.
Dec 20, 2016	Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-...	Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resultin...	Class II	Mylan LLC.
Dec 19, 2016	Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex...	Superpotent Drug: Product may not meet specifications throughout shelf life.	Class III	Apotex Inc.
Dec 16, 2016	MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per c...	Failed Impurities/Degradation Specifications	Class II	Fresenius Kabi USA, LLC
Dec 16, 2016	Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only,...	Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.	Class III	Aurobindo Pharma USA Inc
Dec 15, 2016	Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bot...	Lack of Sterility Assurance	Class II	Meta Pharmacy Services
Dec 15, 2016	Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-...	CGMP Deviations	Class II	Gentell, Inc
Dec 15, 2016	Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell...	CGMP Deviations	Class II	Gentell, Inc
Dec 15, 2016	AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused p...	Lack of Assurance of Sterility: Potential cracks in glass vials	Class II	Amgen, Inc.
Dec 14, 2016	Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spra...	Defective Delivery System: out of specification result for droplet size distribution at the d90 m...	Class III	Roxane Laboratories, Inc.
Dec 14, 2016	Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex I...	CGMP Deviations	Class II	Apotex Corp.
Dec 14, 2016	Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex In...	CGMP Deviations	Class II	Apotex Corp.
Dec 13, 2016	Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC ...	Subpotent Drug: out of specification results for assay test.	Class III	Sandoz Inc
Dec 13, 2016	Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immu...	Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled...	Class I	Pacific Medical Solutions
Dec 12, 2016	VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic...	cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.	Class III	VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016	Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing ...	cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.	Class III	VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016	Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Min...	cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.	Class III	VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016	Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Di...	cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.	Class III	VIRTUS PHARMACEUTICALS OPCO II L
Dec 12, 2016	Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65...	Failed Dissolution Specifications	Class II	Amneal Pharmaceuticals LLC
Dec 9, 2016	SLIMFIT X capsules, packaged in a 60-cont bottle	Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibut...	Class I	Jersey Shore Supplements, LLC
Dec 7, 2016	Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10...	Subpotent Drug: Out of specification result for pramoxine hydrochloride	Class III	Novum Pharma, LLC
Dec 6, 2016	INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only,...	Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed vari...	Class III	Cipher Pharmaceuticals US LLC
Dec 6, 2016	Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav...	Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.	Class II	Baxter Healthcare Corporation
Dec 6, 2016	10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx on...	Discoloration: there were customer reports of yellow discolored solution. The yellow coloration i...	Class II	Baxter Healthcare Corporation
Dec 2, 2016	Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, pa...	Subpotent Drug	Class III	Ecolab, Inc.
Dec 2, 2016	Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, R...	Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 25...	Class III	Shire PLC
Dec 1, 2016	Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ...	Failed Dissolution Specifications	Class III	Teva Pharmaceuticals USA
Nov 30, 2016	MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Sta...	Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active...	Class I	MS Bionic
Nov 23, 2016	Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count b...	Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.	Class I	Jeffreys Drug Store
Nov 22, 2016	Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed...	Labeling: Label Mix Up- Incorrect back label applied to the product.	Class III	Les Emballages Knowlton Inc.
Nov 22, 2016	PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop...	Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.	Class III	Pfizer Inc.
Nov 18, 2016	Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag...	Lack of Assurance of Sterility - the firm is recalling select sterile drug products.	Class II	Cantrell Drug Company
Nov 18, 2016	Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag...	Lack of Assurance of Sterility - the firm is recalling select sterile drug products.	Class II	Cantrell Drug Company

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.