Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Low |
| Status | ongoing |
| Recall date | November 11, 2025 |
| Reported | December 17, 2025 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Country / region | United States NJ |
Hazard
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Affected products
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
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