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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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.
Part of a larger recall action
This product is one of 6 recalled by Macleods Pharma Usa Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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Same hazard · azido impurity
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Similar recalls
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