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Browse Drug Recalls

3 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3 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 3 FDA drug recalls.

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DateProductReasonClassFirm
Jun 6, 2018 Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, pa... Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. Class II Pharmalucence, Inc.
Apr 10, 2018 Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 co... Failed Stability Specifications Class II Pharmalucence, Inc.
May 30, 2013 Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injectio... Presence of Particulate Matter; particulate found in retain samples Class III Pharmalucence, 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.