Browse Drug Recalls

1,702 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,702 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 1,702 FDA drug recalls, Class III.

Clear
DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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-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 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 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 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 2, 2016 Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, pa... Subpotent Drug Class III Ecolab, Inc.
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 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 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 17, 2016 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5... Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon... Class III West-Ward Pharmaceuticals Corp.
Nov 8, 2016 Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.... Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and ... Class III Care-Tech Laboratories, Inc.
Nov 4, 2016 Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted)... Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the stren... Class III West-Ward Pharmaceuticals Corp.
Nov 3, 2016 Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 03... Failed Impurities/Degradation Specifications: OOS results for known compound. Class III Mylan Pharmaceuticals Inc.
Nov 2, 2016 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 3... Failed Dissolution Specifications; 6 month time point Class III Zydus Pharmaceuticals USA Inc
Nov 1, 2016 Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, ... Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... Class III Teva Pharmaceuticals USA
Nov 1, 2016 Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, ... Failed Content Uniformity: Product was out of specification for spray content uniformity obtained... Class III Teva Pharmaceuticals USA
Oct 28, 2016 KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP,... Failed Stability Specifications: Low Out of Specification results for alcohol content. Class III Sun Pharmaceutical Industries, Inc.
Oct 27, 2016 Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-co... Failed Dissolution Specifications: The firm was notified that there was a dissolution out of spec... Class III Amerisource Health Services
Oct 20, 2016 FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx on... Labeling: Label error on declared strength. Package Insert -Error in the Description section of t... Class III CutisPharma, Inc.
Oct 20, 2016 FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx ... Labeling: Label error on declared strength. Package Insert -Error in the Description section of t... Class III CutisPharma, Inc.
Oct 19, 2016 Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM ... Labeling: Missing Label Class III Sandoz Inc
Oct 19, 2016 Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-coun... Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be a... Class III Janssen Ortho L.L.C.
Oct 18, 2016 Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 O... Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of... Class III GSK Consumer Healthcare
Oct 18, 2016 HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepare... Subpotent Drug: due to failed potency results of 74% (spec. 80-125%). Class III Town and Country Compounding and Consultation S...
Oct 13, 2016 AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Indi... Presence of Foreign Tablets/Capsules Class III Amerisource Health Services
Oct 13, 2016 Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd:... Failed impurities/degradation specifications: due to out-of-specification result for the Related ... Class III Dr. Reddy's Laboratories, Inc.
Oct 12, 2016 HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection... Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units inste... Class III Pharm D Solutions, LLC
Oct 12, 2016 Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only,... Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly... Class III Pharm D Solutions, LLC
Oct 6, 2016 NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and d... Presence of Foreign Tablets/Capsules Class III Actavis Elizabeth LLC
Sep 30, 2016 Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC... Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufac... Class III Amerisource Health Services
Sep 28, 2016 Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 28, 2016 Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 27, 2016 Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol table... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, ... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablet... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 27, 2016 Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02... Subpotent Drug; Ethinyl Estradiol Class III Par Pharmaceutical, Inc.
Sep 22, 2016 PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 22, 2016 PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA
Sep 22, 2016 PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pha... Failed Impurities/Degradation Specifications: out of specification test results for impurities du... Class III Teva Pharmaceuticals USA

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.