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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 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 12 FDA drug recalls.

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DateProductReasonClassFirm
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.
Oct 7, 2025 Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottl... Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, ... Class II Rising Pharma Holding, Inc.
Mar 5, 2025 Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only,... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Dec 30, 2024 Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Dis... CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Dec 30, 2024 Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000... CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Dec 30, 2024 Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30)... CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Nov 19, 2024 Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Di... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Nov 19, 2024 Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit 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.
May 16, 2024 Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Risin... Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Pack... Class III Rising Pharma Holding, Inc.
Dec 29, 2023 buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bo... Presence of Foreign Tablets/Capsules Class II Rising Pharma Holding, 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.