Browse Drug Recalls

22 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 22 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 22 FDA drug recalls.

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DateProductReasonClassFirm
Dec 23, 2024 Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx on... Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... Class II Viatris Inc
Dec 23, 2024 Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx onl... Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Apr 30, 2024 Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Onl... Failed Impurities/Degradation Specifications Class II Viatris Inc
Apr 30, 2024 Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Onl... Failed Impurities/Degradation Specifications Class II Viatris Inc
Apr 25, 2024 Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for... Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing ... Class III Viatris Inc
May 25, 2023 Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II Viatris Inc
Oct 21, 2022 Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharma... Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. Class II Viatris Inc
Oct 7, 2022 Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. Class I Viatris Inc
Sep 21, 2022 Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 ... Presence of Particulate Matter: A complaint was received for the presence of a single strand of h... Class II Viatris Inc
Apr 28, 2022 Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx onl... Failed Dissolution Specifications: low out of specification results for dissolution. Class II Viatris Inc
Apr 28, 2022 alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr... Failed Dissolution Specifications: low out-of-specification dissolution test results observed. Class II Viatris 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.