Macleods Pharma recalls
FDA enforcement reports naming Macleods Pharma Usa Inc as the recalling firm.
- Recall reports
- 34
- Class I (serious)
- 0
- Most recent report
- Apr 1, 2026
- Apr 1, 2026Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured fo…Drug · MACLEODS PHARMA USA, INCSubpotent DrugClass II
- May 22, 2024Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12Drug · MACLEODS PHARMA USA, INCPresence of foreign substance: plastic-like substance.Class II
- Jan 25, 2023Levofloxacin Tablets, USP 500 mgDrug · MACLEODS PHARMA USA, INCMismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.Class III
- Jul 13, 2022Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for…Drug · Macleods Pharma Usa IncShortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.Class II
- Jul 6, 2022Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC…Drug · Macleods Pharma Usa IncCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsClass II
- May 11, 2022Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottle…Drug · Macleods Pharma Usa IncCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsClass II
- May 11, 2022Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 9…Drug · Macleods Pharma Usa IncCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsClass II
- May 11, 2022Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 10…Drug · Macleods Pharma Usa IncCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsClass II
- May 11, 2022Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90…Drug · Macleods Pharma Usa IncCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsClass II
- May 11, 2022Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12Drug · Macleods Pharma Usa IncCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsClass II
- Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12
- Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macl…
- Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Ph…
- Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, M…
- Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tab…
- Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Do…
- Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Ta…
- Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods…
- Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for:…
- Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count b…
- Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for…
- Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured f…
- Pramipexole Dihydrochloride Tablets 0
- Tamsulosin Hydrochloride Capsules, USP 0
- Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pha…
- Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only,…
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12
- Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods…
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles,…
- Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Man…
- Telmisartan and Hyrdochlorothiazide Tablets 40mg/12
- Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12
- Pramipexole Dihydrochloride Tablets 0
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