Browse Drug Recalls
27 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 27 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 27 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 5, 2023 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured B... | Failed Moisture Limits: Water (moisture) content above the approved product specifications. | Class II | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Mar 27, 2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Class III | Teva Pharmaceuticals USA Inc |
| Feb 23, 2023 | Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op... | Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo... | Class II | Teva Pharmaceuticals USA Inc |
| Feb 22, 2023 | Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | Teva Pharmaceuticals USA Inc |
| Aug 29, 2022 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually... | Class II | Teva Pharmaceuticals USA Inc |
| Aug 23, 2022 | Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distribute... | CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ing... | Class II | Teva Pharmaceuticals USA Inc |
| Jul 22, 2022 | Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom... | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for... | Class III | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jun 29, 2022 | Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O... | Superpotent Drug: Out of specification assay result was obtained during stability testing. | Class II | Teva Pharmaceuticals USA Inc |
| Jun 14, 2022 | Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuti... | Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| May 18, 2022 | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Cart... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class III | Teva Pharmaceuticals USA Inc |
| May 11, 2022 | Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... | Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... | Class I | Teva Pharmaceuticals USA Inc |
| Apr 15, 2022 | Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... | cGMP Deviations | Class II | Teva Pharmaceuticals USA Inc |
| Mar 29, 2022 | IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, ... | Presence of Particulate Matter: Product was found to contain silica and iron oxide | Class I | Teva Pharmaceuticals USA Inc |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx onl... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials,... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2021 | Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, p... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Sep 4, 2020 | Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal... | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Class II | Teva Pharmaceuticals USA |
| Jul 16, 2018 | Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Ma... | API material used in the manufacturing of the product did not receive regulatory approval prior t... | Class II | 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.