Varenicline Tablets, 1mg, 56 Tablets, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, Nj 08540, Made In India, Ndc 43598-908-56
Recall Summary Dr. Reddy's Laboratories is recalling Varenicline 1mg tablets (a prescription medication used to help quit smoking) because testing showed the drug contained less active ingredient than required. The affected product was distributed nationwide, and this is a Class I recall, meaning the product could cause serious health problems. The recall involves a specific lot of 56-tablet packages with NDC number 43598-908-56 manufactured in India.
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Reason
- Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-11
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distributed Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3054b8f9-168a-4981-b02a-0d8f4b6f26d1