Browse Drug Recalls
34 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 34 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 34 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2025 | Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for:... | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. | Class III | Macleods Pharmaceuticals Ltd |
| May 29, 2025 | Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, M... | Presence of a foreign substance: black hair found embedded in tablet. | Class III | Macleods Pharmaceuticals Ltd |
| 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 |
| May 7, 2024 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-c... | Presence of foreign substance: plastic-like substance. | Class II | MACLEODS PHARMA USA, INC |
| Jan 5, 2023 | Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for... | Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package inse... | Class III | MACLEODS PHARMA USA, INC |
| 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 |
| May 11, 2022 | Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| May 11, 2022 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distribute... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| May 11, 2022 | Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distribut... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| 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 |
| 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 |
| Oct 18, 2021 | Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2... | 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 |
| Mar 15, 2021 | Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only ND... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health 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 |
| 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 |
| Jan 11, 2019 | Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufact... | Defective Container; complaints of leakage. | Class III | Oxalis Labs |
| 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.