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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.