D-0326-2021 Class I Terminated
FDA drug recall D-0326-2021 was initiated by Alembic Pharmaceuticals Limited on Mar 17, 2021 and is designated Class I. Reason for recall: Labeling: Label-mixup The recall status is terminated (terminated Dec 5, 2022). Affected quantity: 12288 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 14, 2021
- Initiation Date
- Mar 17, 2021
- Termination Date
- Dec 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12288 bottles
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 1905005661, Exp March 2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0326-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026