Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 25 mg, because FDA labs found an impurity above acceptable levels.
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, which corresponds to a Severe severity score under the rubric for significant potential health risks.
Plain-English summary
Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 25 mg, in 90-count and 1000-count bottles. The recall involves 133,992 bottles distributed nationwide in the United States and Puerto Rico. The specific lots affected are 4DU1E005, 4DU1E006, 4DU1E007, and 4DU1E008, all with an expiration date of 1/31/2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels exceeding the interim acceptable daily intake.
Consumers should check their medication bottles for the NDC numbers 13668-113-90 or 13668-113-10 and the lot numbers listed above. If the medication matches these details, patients should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking…
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 133,992
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 (7)
- Count
- lots
- expiry: [90-count bottle ] Lots 4DU1E005
- 4DU1E006
- 4DU1E008
- exp 1/31/2021
- Lots 4DU1E007
Distribution
Part of a larger recall action
This product is one of 6 recalled by Torrent Pharma 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.
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