Dr. Reddy's Laboratories, Inc. 2025-12-17 Health moderate FDA
Health · FDA · Recall #FDA-D-0219-2026
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories… Recall
Issued December 17, 2025 · Dr. Reddy's Laboratories, Inc.
In December 2025, Dr. Reddy's Laboratories, Inc. recalled the Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories…, a moderate health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
What you should do
- 1 Stop using Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Dr. Reddy's Laboratories, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Dr. Reddy's Laboratories, Inc.
- Category
- Health
- Recall date
- December 17, 2025
- Units affected
- Not reported
- Sold at
- Distributed Nationwide
- Recall number
- FDA-D-0219-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Dr. Reddy's Laboratories, Inc. has 17 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.