Macleods Pharma Usa Inc
Complete recall history across all FDA and CPSC categories — 28 total recalls
Macleods Pharma Usa Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (28)
FDA drug safety enforcement actions by Macleods Pharma Usa Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| 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 ... | Class II |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mar 10, 2022 | Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... | FAILED CONTENT UNIFORMITY SPECIFICATIONS | Class III |
| Feb 16, 2022 | Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M... | cGmp Deviations | Class II |
| Feb 15, 2022 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ... | cGMP deviations | Class II |
| Aug 2, 2021 | Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for:... | Presence of foreign matter | Class II |
| Mar 22, 2021 | Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufact... | Failed Impurities/Degradation Specifications | Class III |
| 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 t... | Class III |
| Jan 20, 2020 | Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... | Failed Dissolution Specifications: testing revealed low out of specification... | Class III |
| Sep 23, 2019 | Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manu... | Superpotent | Class II |
| 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 Pramipe... | Class III |
| Jul 17, 2019 | Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... | Failed Dissolution Specifications | Class II |
| 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) d... | Class II |
| 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) d... | Class II |
| 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) d... | Class II |
| 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) d... | Class II |
| 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) d... | Class II |
| 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... | Class II |
| Feb 25, 2019 | Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, ... | Failed Content Uniformity Specifications: The product is out of specification... | Class II |
| 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... | Class II |
| Feb 21, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 coun... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impur... | Class II |
| 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 ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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