FDA Recall D-0219-2026
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class III Ongoing 184 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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 for recall
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Recall record
- Recall number
D-0219-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide
- Recall initiated
- 2025-11-11
- Classified by FDA Center
- 2025-12-05
- FDA published
- 2025-12-17
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- VARENICLINE TARTRATE
- Generic name(s)
- VARENICLINE TARTRATE
- Manufacturer(s)
- Dr. Reddys Laboratories Inc.
- NDC(s)
43598-022, 43598-907, 43598-908, 43598-023- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.