Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tabl... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distribut... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 coun... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only,... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only... | Presence of Particulate Matter: particulate matter identified after reconstitution. | Class II | Pfizer Inc. |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only,... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 28, 2020 | Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: ... | Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. | Class II | Lupin Pharmaceuticals Inc. |
| May 28, 2020 | Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single p... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distrib... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distri... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 ... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Inject... | Subpotent drug - Product did not contain drug. | Class II | QuVa Pharma, Inc. |
| May 27, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable in... | Class II | Apotex Inc. |
| May 22, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Some bottles may contain mixed strengths of the product. | Class II | Teva Pharmaceuticals USA |
| May 22, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Some bottles may contain mixed strengths of the product. | Class II | Teva Pharmaceuticals USA |
| May 22, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Some bottles may contain mixed strengths of the product. | Class II | Teva Pharmaceuticals USA |
| May 22, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto... | Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l... | Class II | The Harvard Drug Group |
| May 19, 2020 | LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in ... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| May 19, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... | Class II | American Health Packaging |
| May 19, 2020 | LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches pe... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| May 19, 2020 | Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured ... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| May 19, 2020 | Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 pat... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| May 15, 2020 | Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa,... | Failed impurities/ degradation specifications: Out of specification for organic impurities. | Class II | TRIOVA PHARMACEUTICALS LLC |
| May 15, 2020 | EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate... | Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allow... | Class II | Eco Lips Inc |
| May 15, 2020 | Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... | Failed dissolution specifications | Class II | PD-Rx Pharmaceuticals, Inc. |
| May 13, 2020 | Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... | Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... | Class II | West-Ward Columbus Inc |
| May 11, 2020 | Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Curcumin, 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| May 5, 2020 | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,... | Discoloration: Out-of-specification results for appearance obtained during routine stability test... | Class II | Mylan Institutional LLC |
| Apr 21, 2020 | Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1... | Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins | Class II | Sandoz, Inc |
| Apr 20, 2020 | Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: ... | Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 se... | Class II | Lupin Pharmaceuticals Inc. |
| Apr 20, 2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class II | Fresenius Kabi USA, LLC |
| Apr 15, 2020 | Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Di... | CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... | Class II | Amneal Pharmaceuticals of New York, LLC |
| Apr 15, 2020 | Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-coun... | cGMP Deviations | Class II | H J Harkins Company Inc dba Pharma Pac |
| Apr 15, 2020 | Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin... | Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 14, 2020 | Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC... | cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. | Class II | B & B Pharmaceuticals, Inc. |
| Apr 6, 2020 | Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL b... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy,... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medici... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medic... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, P... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
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.