FDA Drug recall D-0219-2026
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-90…
- FDA Drug
- Class III
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class III recall of Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-90… by Dr Reddy S Laboratories, citing sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0219-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-11 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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.
Identifiers
| ndc | 43598-907-56 |
|---|---|
| ndc | 43598-908-56 |
| ndc | 43598-023-53 |
| ndc | 43598-022-56 |
| code_info | Lot # F2400244, Exp Date: 10/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class III · 2024-11-27 · Dr Reddy S Laboratories
All Dr Reddy S Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0219-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.