D-0219-2026 Class III Ongoing
FDA drug recall D-0219-2026 was initiated by Dr. Reddy's Laboratories, Inc. on November 11, 2025 and is designated Class III. Reason for recall: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. The recall status is ongoing. Affected quantity: 4800 54-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 17, 2025
- Initiation Date
- November 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4800 54-count bottles
Product Description
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Reason for Recall
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Distribution Pattern
Distributed Nationwide
Code Information
Lot # F2400244, Exp Date: 10/31/2026