Varenicline Tablets — Class III drug recall D-0219-2026
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2025-12-17, distributed nationwide. Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below s
| Recall number | D-0219-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2025-11-11 |
| Classified | 2025-12-05 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 43598-0022, 43598-0022-56, 43598-0023, 43598-0023-53, 43598-0907, 43598-0907-56, 43598-0908, 43598-0908-56 |
| Lot numbers | F2400244 |
| Expiration dates | 2026-10-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0219-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.