Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in…
- Recall date
- November 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0219-2026
- FDA classification
- Class III
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Distributed Nationwide
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
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