Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity
Macleods Pharma USA Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant safety concerns like impurities in active ingredients.
Plain-English summary
Macleods Pharma USA Inc. is recalling Losartan Potassium Tablets, 50 mg, 1000 tablets per bottle. The recall involves 4,277 bottles, totaling 4,277,000 tablets. The product is distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity known as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments. The specific lot code for the recalled product is BLI710A, with a manufacturing date of November 2019.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription 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 (1)
- BLI710A Nov 2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
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