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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Nov 22, 2024 Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL ... Failed Stability Specifications Class II Jubilant Draximage Inc., dba Jubilant Radiopharma
Jun 16, 2022 Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregat... Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. Class II Jubilant Draximage Inc
Mar 19, 2020 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... Failed Stability Specifications Class II Jubilant Draximage Inc
Mar 11, 2016 SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by J... Labeling: Label Error on Declared Strength Class III Jubilant Draximage 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.