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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 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 9 FDA drug recalls.

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DateProductReasonClassFirm
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a va... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Jan 14, 2020 Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp.,... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Spectrum Laboratory Products
Dec 11, 2019 Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronize... Subpotent Drug: Supplier indicated assay results did not meet specifications. Class II Spectrum Laboratory Products
Sep 12, 2019 Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG... CGMP Deviations: Received notice from supplier that there is potential glass contamination. Class II Spectrum Laboratory Products
Apr 13, 2017 Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg con... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 13, 2017 Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Pl... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Aug 1, 2016 Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical M... Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. Class II Spectrum Laboratory Products, Inc.
Jul 18, 2014 Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP... CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Class II Spectrum Laboratory Products

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.