Browse Drug Recalls
13 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 13 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 13 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 3, 2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... | Class II | Rising Pharma Holding, Inc. |
| Nov 19, 2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Class II | Rising Pharma Holding, Inc. |
| Jun 24, 2024 | Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne ... | Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testin... | Class III | Rising Pharma Holding, Inc. |
| Nov 15, 2019 | Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi... | Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... | Class III | Rising Pharmaceuticals, Inc. |
| Nov 15, 2019 | Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T... | Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... | Class III | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Heal... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Apr 13, 2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx... | Subpotent Drug | Class II | Lyne Laboratories, Inc. |
| Apr 13, 2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufac... | Subpotent Drug | Class II | Lyne Laboratories, Inc. |
| Apr 13, 2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx... | Subpotent Drug | Class II | Lyne Laboratories, Inc. |
| Jun 7, 2016 | Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in... | Subpotency: product assayed and found OOS for cyproheptadine | Class III | Lyne Laboratories, 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.