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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Dec 23, 2024 Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, ... Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Astellas Pharma US Inc.
Dec 23, 2024 Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Produc... Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules Class I Astellas Pharma US Inc.
Jan 22, 2018 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... Labeling: Label Error on Declared Strength Class II Astellas Pharma US Inc
Sep 15, 2014 Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured ... Failed Dissolution Specifications: The product did not meet the acceptance criteria for the disso... Class II Astellas Pharma US Inc
Jun 19, 2013 AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial,... Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on cert... Class II Astellas Pharma US 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.