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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Oct 20, 2025 NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx onl... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Oct 10, 2025 Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottl... Failed Dissolution Specifications Class II Lannett Company Inc.
Aug 19, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amph... Class II Lannett Company Inc.
Aug 11, 2025 Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist... Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained... Class II Lannett Company Inc.
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... Failed Impurity/Degradation Specifications Class III Lannett Company Inc.
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [... Failed Impurity/Degradation Specifications Class III Lannett Company Inc.
Feb 9, 2022 Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE ... Failed Impurities/Degradation Specifications: Out of specification results for related substances. Class II Lannett Company, Inc.
Aug 10, 2020 Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannet... Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contai... Class II Lannett Company, Inc.
Jul 27, 2020 Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Dec 6, 2019 Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, D... Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total ... Class I Lannett Company, Inc.
Oct 28, 2019 Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Di... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Lannett Company, Inc.
Oct 11, 2018 HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP... CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for... Class II Lannett Company, Inc.
Sep 17, 2018 robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ... Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly... Class I Endo Pharmaceuticals, Inc.
Mar 31, 2015 C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC... Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as... Class II Cody Laboratories, 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.