Varenicline Tablets recall
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Why was Varenicline Tablets recalled?
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # F2400244, Exp Date: 10/31/2026
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 4800 54-count bottles
- Distribution
- Distributed Nationwide
- Recall date
- December 17, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)