Recalls / Class III
Class IIID-0219-2026
Product
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Brand name
- Varenicline Tartrate
- Generic name
- Varenicline Tartrate
- Route
- Oral
- NDCs
- 43598-022, 43598-907, 43598-908, 43598-023
- FDA application
- ANDA215931
- Affected lot / code info
- Lot # F2400244, Exp Date: 10/31/2026
Why it was recalled
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddys Laboratories Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 College Rd E Ste 4000, N/A, Princeton, New Jersey 08540-6636
Distribution
- Quantity
- 4800 54-count bottles
- Distribution pattern
- Distributed Nationwide
Timeline
- Recall initiated
- 2025-11-11
- FDA classified
- 2025-12-05
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0219-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.