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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Nov 25, 2019 Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Pa... Failed Impurities/Degradation Specifications Class II Medisca, Inc.
Sep 14, 2017 Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredien... CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pha... Class II Medisca, Inc.
Apr 3, 2017 ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-08... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 gram... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Apr 3, 2017 ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b... cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a r... Class II Medisca, Inc.
Oct 21, 2013 Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For ... Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was fo... Class I Medisca 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.