Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 6233

FDA recall notice · announced April 14, 2021 · Alembic Pharmaceuticals Limited

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30

Reason for recall

Labeling: Label-mixup

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 1905005661, Exp March 2022
Quantity: 12288 bottles
Status: Terminated
Products in this recall event:
- Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceutica (D-0326-2021)

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