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Browse Drug Recalls

25 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 25 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 25 FDA drug recalls.

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DateProductReasonClassFirm
Dec 4, 2024 DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharma... CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso... Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limite... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Jun 6, 2022 Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed a... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 6, 2022 Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 6, 2022 Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed a... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Oct 6, 2020 metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: ... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II PD-Rx Pharmaceuticals, Inc.
Oct 6, 2020 metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Ok... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II PD-Rx Pharmaceuticals, Inc.
Sep 17, 2020 Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), L... CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured ... Class II PD-Rx Pharmaceuticals, Inc.
Jun 5, 2020 metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II PD-Rx Pharmaceuticals, Inc.
Jun 5, 2020 metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II PD-Rx Pharmaceuticals, Inc.
May 15, 2020 Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... Failed dissolution specifications Class II PD-Rx Pharmaceuticals, Inc.
Jan 10, 2020 ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 430... CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts ... Class II PD-Rx Pharmaceuticals, Inc.
Mar 8, 2019 Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorpo... CGMP deviation: Product found to contain trace amounts of NMBA Class II PD-Rx Pharmaceuticals, Inc.
Aug 7, 2018 Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 5... Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged l... Class II PD-Rx Pharmaceuticals, Inc.
Jan 25, 2018 PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Aug 11, 2017 Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-cou... Failed Impurities/Degradation Specifications:Out of specification results for individual unknown ... Class III PD-Rx Pharmaceuticals, Inc.
Jul 28, 2017 Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals In... Failed Tablet/Capsule Specification: out of specification for tablet weight. Class II PD-Rx Pharmaceuticals, Inc.
Jul 21, 2015 Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC ... Failed impurities/Degradation specifications: out of specification results for individual unknown... Class III PD-Rx Pharmaceuticals, Inc.
Jul 10, 2015 Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Pac... cGMP Deviations Class II PD-Rx Pharmaceuticals, Inc.
Apr 29, 2015 Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) ... cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm... Class II PD-Rx Pharmaceuticals, Inc.
Apr 29, 2015 Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 c... cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm... Class II PD-Rx Pharmaceuticals, 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.