Varenicline tablets recalled after an assay value fell below specification
Dr. Reddy's Laboratories is recalling 4,800 bottles of Varenicline Tablets, 1mg, after the assay value for the affected lot fell below the specification limit at nine-month stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites a below-specification assay result with no stated clinical consequence.
Plain-English summary
Varenicline Tablets, 1mg, 56 tablets, distributed by Dr. Reddy's Laboratories Inc. of Princeton, New Jersey, made in India, under NDC 43598-908-56, are being recalled.
The reason given in the enforcement record is a subpotent drug: during the 9-month stability test conducted, the assay value for the affected lot was below the specification limit.
The record lists 4,800 54-count bottles from lot F2400244, expiry 10/31/2026. Distribution was nationwide. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- VARENICLINE TARTRATE (VARENICLINE TARTRATE)
- Brand
- VARENICLINE TARTRATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Smoking cessation
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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