Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Reported: December 17, 2025 Initiated: November 11, 2025 #D-0219-2026
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 4800 54-count bottles
- Distribution
- Distributed Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 4800 54-count bottles.
Why was this product recalled? ▼
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2025. Severity: Low. Recall number: D-0219-2026.
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