Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L)... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 20, 2020 | Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) ... | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) d... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 17, 2020 | Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Lim... | Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle o... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 16, 2020 | HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biol... | Labeling: Error on Declared Strength | Class II | Grato Holdings, Inc. |
| Jul 14, 2020 | Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: A... | Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not ... | Class II | Teva Pharmaceuticals USA |
| Jul 14, 2020 | Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Dis... | cGMP Deviations | Class II | Soluciones Cosmeticas, SA de CV |
| Jul 13, 2020 | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for... | SUBPOTENT DRUG | Class II | Bausch Health Companies, Inc. |
| Jul 13, 2020 | Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on... | Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta... | Class III | Fresenius Kabi USA, LLC |
| Jul 11, 2020 | Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcoh... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packa... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Pack... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), pac... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost ... | CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... | Class II | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 10, 2020 | Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Man... | cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufac... | Class II | Keryx Biopharmaceuticals, Inc. |
| Jul 9, 2020 | Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottl... | CGMP Deviations: Products manufactured at the same site were FDA testing found below the label cl... | Class II | Maquiladora Miniara Sa De Cv |
| Jul 7, 2020 | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma... | Presence of Particulate Matter | Class I | Mylan Institutional LLC |
| Jul 7, 2020 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottle... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 7, 2020 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV reg... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottle... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 7, 2020 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV reg... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottle... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 7, 2020 | Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 6, 2020 | Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0... | SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. | Class III | Allergan PLC |
| Jul 6, 2020 | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distr... | SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. | Class III | Allergan PLC |
| Jul 6, 2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... | Cross contamination with other products - OOS discovered during routine stability testing for hig... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 3, 2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bott... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Granules Pharmaceuticals Inc |
| Jul 2, 2020 | Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richm... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterP... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx o... | Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. | Class II | Lupin Pharmaceuticals Inc. |
| Jul 2, 2020 | Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPh... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... | Chemical Contamination: Product contains methanol. | Class I | AAA Cosmetica, SA de CV |
| Jul 2, 2020 | Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 ... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterP... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, Maste... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446... | Labeling: Label Error on Declared Strength | Class II | Edge Pharma, LLC |
| Jul 2, 2020 | Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPha... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm 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.