Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Carcinogen
Macleods Pharma USA is recalling specific bottles of Losartan Potassium and Hydrochlorothiazide tablets because a carcinogen 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 recall is classified as FDA Class II and involves a carcinogen impurity (NDEA), which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risks).
Plain-English summary
Macleods Pharma USA, Inc. is recalling 9,695 bottles of Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles. The affected product is prescription-only and was manufactured by Macleods Pharmaceuticals Ltd. in India. The specific lot number is BLM715A with an expiration date of Jul-19.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation involving the presence of N-Nitrosodimethylamine (NDEA), a known carcinogen impurity, detected in the active ingredient. This classification is designated as FDA Class II.
The affected units were distributed in New Jersey, New York, and Florida. Patients and consumers who have this specific medication should contact their healthcare provider or pharmacist for guidance on alternative treatment options and should not continue using the recalled product.
The recalled product
- Product
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 9,695
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 (2)
- Lot BLM715A
- Jul-19
Distribution
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