Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity
Macleods Pharma USA Inc. is recalling Losartan Potassium 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 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: The recall is classified as FDA Class II, and the hazard involves a potential carcinogenic impurity (NMBA) without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Macleods Pharma USA Inc. is recalling Losartan Potassium Tablets, USP 50 mg. The recall involves 47,520 bottles, containing a total of 4,276,800 tablets, which were distributed nationwide. The specific lot code is BLI711A, with a manufacturing date of November 2019.
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 medication should check their bottles for the lot code BLI711A. If the lot matches, they should stop using the product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Medication
- Hazard
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)
- BLI711A 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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