Browse Drug Recalls
120 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 120 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 120 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 24, 2026 | Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs... | Failed Dissolution Specifications | Class II | MYLAN PHARMACEUTICALS INC |
| Mar 7, 2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose ... | Super-Potent Drug: Out of specification potency results were obtained. | Class II | Mylan Institutional, Inc. |
| Mar 7, 2025 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose... | Super-Potent Drug: Out of specification potency results were obtained. | Class II | Mylan Institutional, Inc. |
| Feb 25, 2025 | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Myl... | Failed Dissolution Specifications - low dissolution results | Class II | MYLAN PHARMACEUTICALS INC |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 19, 2024 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton... | Subpotent and Superpotent Drug | Class II | Mylan Institutional, Inc. |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Apr 25, 2024 | Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for... | Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing ... | Class III | Viatris Inc |
| Aug 2, 2023 | Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc... | Failed dissolution specifications - results obtained were below spec average. | Class II | Aurobindo Pharma USA Inc. |
| Oct 21, 2022 | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharma... | Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. | Class II | Viatris Inc |
| Jul 5, 2022 | Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 m... | Labeling: Missing label: Label missing from some prefilled pens. | Class I | Mylan Pharmaceuticals Inc |
| Apr 12, 2022 | Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), pac... | Labeling: Missing label on the vial | Class I | Mylan Pharmaceuticals Inc |
| Apr 1, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit ... | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Apr 1, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit ... | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Apr 1, 2022 | Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufact... | Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results... | Class II | Mylan Pharmaceuticals Inc |
| Jan 26, 2022 | CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bott... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Sep 13, 2021 | Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for:... | Failed Impurities/Degradation Specifications; out of specification for Related Compound | Class III | Viatris |
| Mar 15, 2021 | Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/d... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Oct 2, 2020 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, pac... | Out-of-specification organic impurity results obtained during routine stability testing. | Class III | Mylan Pharmaceuticals Inc. |
| Mar 23, 2020 | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceutical... | Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule... | Class III | Mylan Pharmaceuticals Inc. |
| Mar 9, 2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharma... | Presence of particulate matter. presence of metal particles. | Class II | Mylan Pharmaceuticals Inc. |
| Jan 7, 2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 7, 2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... | Class II | Mylan Pharmaceuticals Inc. |
| Oct 23, 2019 | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for:... | Presence of Foreign Substance | Class II | Mylan Pharmaceuticals Inc. |
| Oct 18, 2019 | Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Ph... | Failed Dissolution Specification: Low out of specification dissolution results. | Class II | Mylan Pharmaceuticals Inc. |
| Sep 6, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: ... | Failed Impurities/Degradation Specifications:OOS for unknown impurity. | Class III | Mylan Pharmaceuticals Inc. |
| Feb 13, 2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count ... | Failed Impurities/Degradation Specifications: High out of specification results obtained during r... | Class III | Mylan Pharmaceuticals Inc. |
| Feb 1, 2019 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 13... | Defective Container: Potential for broken glass in the neck area of the glass bottles. | Class II | Mylan Pharmaceuticals Inc. |
| Jan 18, 2019 | Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for... | Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected durin... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jan 18, 2019 | Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0... | Failed Impurities/Degradation Specifications: Related compound results obtained during routine st... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count b... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
| Nov 20, 2018 | Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manu... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... | Class II | Mylan Pharmaceuticals Inc. |
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.