Quick Facts at a Glance
- Recall Date
- November 11, 2025
- Hazard Level
- HIGH
- Brands
- VARENICLINE TARTRATE, Dr. Reddys Laboratories Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- VARENICLINE TARTRATE, Dr. Reddys Laboratories Inc.
- Product type
- Varenicline Tablets
- Model numbers
- Lot # F2400244, Exp Date: 10/31/2026
- UPC codes
- 43598-022, 43598-907, 43598-908, 43598-023, 43598-907-56, 43598-908-56, 43598-023-53, 43598-022-56
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 11, 2025
Reported by FDA DRUG
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Dr. Reddy's Laboratories, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Varenicline tablets are used as a prescription medication to help adults quit smoking by reducing withdrawal symptoms and cravings. Consumers typically buy this product as part of a smoking cessation plan.
Why This Is Dangerous
The recall is due to the drug being sub potent, meaning it might not deliver the intended effects in helping users quit smoking. This can lead to an ineffective treatment experience for those relying on the medication.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks if they continue using the recalled Varenicline tablets. The urgency to discontinue use is high, as ineffective treatment could hinder smoking cessation efforts.
Practical Guidance
How to identify if yours is affected
- Check the lot number on the bottle.
- Verify if the lot number is F2400244 with an expiration date of October 31, 2026.
- If you possess the affected lot, stop using the product immediately.
Where to find product info
The lot number and expiration date can usually be found on the label of the bottle or packaging.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after your request is submitted.
If the manufacturer is unresponsive
- Contact Dr. Reddy's Laboratories customer service for assistance.
- Follow up with a written request if there is no response within two weeks.
How to prevent similar issues
- Always check for recalls before using prescription medications.
- Consult your healthcare provider regularly about the effectiveness of your treatment.
Documentation advice
Document all correspondence with the manufacturer, including emails and phone calls. Keep receipts and photos of the product as proof of purchase.
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Product Details
The recall affects Varenicline Tablets, 1mg, 56 tablets per bottle, distributed nationwide. The affected lot number is F2400244, with an expiration date of October 31, 2026.
Key Facts
- Recall date: November 11, 2025
- Report date: December 17, 2025
- Quantity recalled: 4,800 bottles
- Manufacturer: Dr. Reddy's Laboratories Inc.
- Country of origin: India
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Safety Guide
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