FDA Drugs recall ·
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr recall
- Recall number
- D-0219-2026
- Date
- (initiated November 11, 2025)
- Company / brand
- Dr. Reddy's Laboratories, Inc.
600 College Rd E Ste 4000, Princeton, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 4800 54-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 it recalled?
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # F2400244, Exp Date: 10/31/2026
Distribution
Distributed Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0219-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.