The Recall Desk
ModerateFDA (Drugs)·D-0219-2026·Announced 2025-12-17

Varenicline Tartrate 1mg Tablets Recalled for Below-Specification Potency

Dr. Reddy's Laboratories is recalling Varenicline Tartrate 1mg tablets (Lot F2400244) distributed nationwide because testing found potency below specification limits.

What this means for you

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: This is an FDA Class III recall for a sub-potency issue where assay values fell below specification. The hazard is a quality and therapeutic effectiveness concern rather than a traditional safety hazard, placing this in the Moderate category typical of Class III recalls.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Varenicline Tartrate 1mg tablets in Lot F2400244 (expiration date 10/31/2026). The affected lot consisted of 4,800 bottles containing 54 tablets each, distributed nationwide.

During a nine-month stability test, the assay value for the affected lot was found to be below the specification limit, indicating the tablets contain less of the active ingredient than intended.

Anyone who has Varenicline Tartrate tablets from Lot F2400244 may be affected. Consumers should consult their healthcare provider or pharmacist regarding this recall.

The recalled product

Product
VARENICLINE TARTRATE (VARENICLINE TARTRATE)
Brand
VARENICLINE TARTRATE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug
Hazard
  • sub-potency

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.

Related recalls

Same category