[pending] VARENICLINE TARTRATE (VARENICLINE TARTRATE)
Pending LLM rewrite. Source: FDA_DRUG D-0219-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
The recalled product
- Product
- VARENICLINE TARTRATE (VARENICLINE TARTRATE)
- Brand
- VARENICLINE TARTRATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # F2400244
- Exp Date: 10/31/2026
Distribution
Distributed nationwide across the United States.
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