Losartan Potassium and Hydrochlorothiazide Tablets Recalled Due to AZIDO Impurity Contamination
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The prescription blood pressure medication was distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a manufacturing quality issue with detected AZIDO impurity above acceptable regulatory limits. The precautionary recall reflects the CGMP deviation and regulatory limit violation rather than any reported adverse health effects.
Plain-English summary
Macleods Pharma USA Inc is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/12.5 mg) due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified AZIDO impurity levels above acceptable regulatory limits.
The recalled product was distributed nationwide in multiple package sizes: 30-count, 90-count, and 1000-count bottles. Affected lot numbers include BLL2107B (exp. 05/2023), BLL2101A (exp. 01/2025), BLL2102A (exp. 02/2025), BLL2103B (exp. 02/2023), and BLL2104A (exp. 05/2023).
The FDA classified this as a Class II recall. Consumers in possession of affected lots should contact their pharmacy or healthcare provider for guidance regarding their medication.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Antihypertensive
- Hazard
- azido-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # BLL2107B
- exp. date 05/2023 BLL2101A
- exp. date 01/2025 BLL2102A
- exp. date 02/2025 BLL2103B
- exp. date 02/2023 BLL2104A
- exp. date 05/2023
UPCs (7)
- 0333342051448
- 0333342050106
- 0333342052100
- 0333342051103
- 0333342052445
- 0333342051073
- 0333342052070
Distribution
Distributed nationwide across the United States.
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