Hetero Labs Recalls Losartan Potassium Tablets Due to Bulging Complaints
Hetero Labs is recalling 43,512 bottles of Losartan Potassium 50 mg tablets due to a complaint of bulging tablets.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a physical defect (bulging tablet) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hetero Labs Limited (Unit V) is recalling 43,512 bottles of Losartan Potassium Tablets USP, 50 mg, 90 count bottles. The product is prescription-only and was manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, by Hetero Labs, Limited, Mahabubragar, India.
The recall was initiated due to a complaint of bulging tablets, which constitutes a failure of tablet/capsule specification. The affected product is identified by Batch # LOA19357A with an expiration date of 09/2021.
The product was distributed to major wholesalers and distributors throughout the United States. Consumers and healthcare providers should check their inventory for this specific batch and expiration date. If found, the product should be returned to the pharmacy or distributor for a refund or replacement.
The recalled product
- Product
- Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
- Manufacturer
- Hetero Labs Limited (Unit V)
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 43,512
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)
- Batch # LOA19357A
- exp. date 09/2021
Distribution
Distribution scope not specified by the agency.
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