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Class II · ModerateActive recall

Sertraline Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # QB00865, exp. date Feb 2028
Where it was soldNationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective container - seal not adhering to bottles

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Pharmaceuticals, Inc., Naples, FL 34108
Brand nameSERTRALINE HYDROCHLORIDE
Generic nameSERTRALINE HYDROCHLORIDE
Active ingredient(s)SERTRALINE HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals Inc.
NDC68180-353-09
Show the full FDA record
Full product labelSertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Recalling firmLupin Pharmaceuticals Inc.
DistributionNationwide.
Quantity52,128 bottles
Recall initiated2025-11-05
Report date2025-12-17
Recall completed—
Recall numberD-0227-2026
ClassificationClass II
FDA statusOngoing
Origin on fileNaples FL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.