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Browse Drug Recalls

10 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 10 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 10 FDA drug recalls.

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DateProductReasonClassFirm
Oct 10, 2025 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips w... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips ... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips w... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Sep 5, 2025 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Dec 20, 2024 Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... Class I ENDO USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, 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.