Lower riskDrug recall · FDA · Published November 5, 2025
Lupin Sertraline Tablets Recall: Defective Bottle Seal Risk
Lupin Pharmaceuticals recalls 100mg sertraline tablets with defective bottle seals that may not stay closed, risking medication exposure. Affected lots: QB00865, exp. Feb 2028.
“Lupin Sertraline Tablets Recall: Defective Bottle Seal Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31644-lupin-sertraline-tablets-recall-defective-bottle-seal-risk. Based on FDA recall #D-0227-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0227-2026%22&limit=1).
The FDA announced on Nov. 5, 2025, that Lupin Pharmaceuticals Inc. is recalling Sertraline Hydrochloride Tablets USP, 100 mg, due to a defective container seal not adhering to bottles. The voluntary Class II recall affects 52,128 bottles distributed nationwide.
The recall is due to a defective container where the seal does not adhere to the bottles. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since Jan. 31, 2013. Recent brand recalls include a Lupin Clobetasol Cream recall for failed content uniformity specifications on Aug. 3, 2026, and a Lupin Glucagon Emergency Kit recall for CGMP deviation risk on June 23, 2026. Other recent recalls of similar products include an Apotex Desmopressin Nasal Spray recall for defective bottle caps risk (April 8, 2026) and Keystone Burkhart Anesthetic Gel and Keystone DHP Topical Anesthetic Gel recalls for defective container risk (May 21, 2026).
How to tell if you have this one
Check for bottles labeled 'Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets' with lot number QB00865 and expiration date February 2028.
Brand
Lupin Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Bottle Seal
Look for bottles where the seal doesn't stay closed. If it's loose, stop using the tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0227-2026 (November 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0227-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.