Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

FDA recall notice · announced September 2, 2020 · Hetero Labs Limited (unit V)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Failed Tablet/Capsule Specification; complaint of bulging tablet

Notes

Distribution: Product was distributed to major wholesalers/distributors throughout the United States.
Lot/code information: Batch # LOA19357A, exp. date 09/2021
Quantity: 43,512 bottles
Status: Terminated
Products in this recall event:
- Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India (D-1545-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.