Browse Drug Recalls

31 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 31 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 31 FDA drug recalls.

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DateProductReasonClassFirm
Nov 25, 2024 Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: M... Failed Impurities/Degradation Specifications Class II Macleods Pharmaceuticals Ltd
Jun 16, 2022 Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufa... Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. Class II Macleods Pharma Usa Inc
Jun 10, 2022 Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 ... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-co... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Mar 10, 2022 Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... FAILED CONTENT UNIFORMITY SPECIFICATIONS Class III Macleods Pharma Usa Inc
Feb 16, 2022 Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M... cGmp Deviations Class II Macleods Pharma Usa Inc
Feb 15, 2022 Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ... cGMP deviations Class II Macleods Pharma Usa Inc
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Uni... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Un... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Aug 2, 2021 Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for:... Presence of foreign matter Class II Macleods Pharma Usa Inc
Mar 22, 2021 Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufact... Failed Impurities/Degradation Specifications Class III Macleods Pharma Usa Inc
Jan 24, 2020 Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, ... Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitaz... Class III Macleods Pharma Usa Inc
Jan 20, 2020 Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... Failed Dissolution Specifications: testing revealed low out of specification result in one lot o... Class III Macleods Pharma Usa Inc
Sep 23, 2019 Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manu... Superpotent Class II Macleods Pharma Usa Inc
Aug 21, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... Class III Macleods Pharma Usa Inc
Jul 17, 2019 Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... Failed Dissolution Specifications Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, US... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tab... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Ma... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tabl... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Jun 20, 2019 Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for:... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Macleods Pharma Usa Inc
Feb 25, 2019 Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottle... Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. Class II Macleods Pharma Usa Inc
Feb 25, 2019 Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, ... Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. Class II Macleods Pharma Usa Inc
Feb 25, 2019 Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx... Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. Class II Macleods Pharma Usa Inc
Feb 21, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 coun... CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... Class II Macleods Pharma Usa Inc
Dec 24, 2015 Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufac... Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. Class II Macleods Pharma Usa 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.