Quick Facts at a Glance
- Recall Date
- November 5, 2025
- Hazard Level
- HIGH
- Brands
- SERTRALINE HYDROCHLORIDE, Lupin Pharmaceuticals, 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
- SERTRALINE HYDROCHLORIDE, Lupin Pharmaceuticals, Inc.
- Product type
- Sertraline Hydrochloride Tablets
- Model numbers
- Lot # QB00865, exp. date Feb 2028
- UPC codes
- 68180-351, 68180-352, 68180-353, 68180-978, 68180-986, 68180-992, 68180-351-08, 68180-351-06 +8 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 5, 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
Defective container - seal not adhering to bottles
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Sertraline Hydrochloride Tablets are prescribed to treat depression, anxiety, and other mood disorders. Patients typically use this medication daily as part of their treatment regimen.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who rely on Sertraline for mental health treatment face potential safety risks. The recall may cause inconvenience and necessitate obtaining replacements.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your bottle against the recall notice.
- Confirm the expiration date is February 2028.
- Contact your healthcare provider for further instructions.
Where to find product info
The lot number and expiration date can usually be found on the bottom or side of the bottle.
What timeline to expect
Expect processing for refunds or replacements to take 4 to 6 weeks.
If the manufacturer is unresponsive
- Follow up with customer service via phone or email.
- Document all communication attempts.
How to prevent similar issues
- Always check for recalls on medications before use.
- Inspect packaging for any visible defects or damage before purchasing.
- Consult with your pharmacist about medication safety.
Documentation advice
Keep receipts, correspondence regarding the recall, and photographs of the affected product.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves Sertraline Hydrochloride Tablets USP, 100 mg, in 90-tablet bottles. Lot number QB00865 with an expiration date of February 2028 is affected. The product was distributed nationwide.
Key Facts
- Recall date: November 5, 2025
- Quantity recalled: 52,128 bottles
- Lot number: QB00865, exp. date: Feb 2028
- Class II recall due to high hazard risk
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.