Losartan Potassium Tablets Recalled for Manufacturing Impurity Above Acceptable Limits
Macleods Pharma USA is recalling Losartan Potassium 50 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Affected lots: BLI2002A, BLI2004A, and BLI2104B.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II pharmaceutical recall involving manufacturing impurity levels above acceptable limits without reported illnesses or injuries. Per the rubric, 'risk-of-harm products where injury has not yet been reported' constitute High severity.
Plain-English summary
Macleods Pharma USA Inc has recalled Losartan Potassium 50 mg tablets distributed nationwide. The recall involves lot numbers BLI2002A and BLI2004A (both expiring 11/2022) and BLI2104B (expiring 05/2023), supplied in 30-count, 90-count, and 1000-count bottles.
The FDA determined that the recalled lots contain AZIDO impurity levels exceeding acceptable limits due to manufacturing deviations. Over 8.6 million tablets from the affected lots were distributed to pharmacies nationwide.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug
- Hazard
- azido-impurity
- manufacturing-deviation
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 (4)
- Lot # BLI2002A
- exp. date 11/2022 BLI2004A
- exp. date 11/2022 BLI2104B
- exp. date 05/2023
Distribution
Distributed nationwide across the United States.
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- HighLosartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels
FDA (Drugs) · 2022-07-06
- HighLosartan Potassium Tablets Recalled for Manufacturing Impurity Issues
FDA (Drugs) · 2022-07-06
- ModerateLosartan Potassium tablets recalled for excessive AZIDO impurity
FDA (Drugs) · 2022-06-08
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