Sertraline Hydrochloride Tablets USP recall
FDA recall D-0227-2026 · initiated Nov 5, 2025
Lupin Pharmaceuticals Inc. recalled Sertraline Hydrochloride Tablets USP in Nov 2025 — an FDA Class II recall (D-0227-2026) because Defective container - seal not adhering to bottles.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container - seal not adhering to bottles
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 52,128 bottles
Details
- Product
- Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide.
- Initiated
- Nov 5, 2025
- FDA report date
- Dec 17, 2025
Frequently asked
- Was Sertraline Hydrochloride Tablets USP recalled?
- Lupin Pharmaceuticals Inc. recalled Sertraline Hydrochloride Tablets USP in Nov 2025 — an FDA Class II recall (D-0227-2026) because Defective container - seal not adhering to bottles. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sertraline Hydrochloride Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0227-2026 was: Defective container - seal not adhering to bottles
- Is a recalled Sertraline Hydrochloride Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sertraline Hydrochloride Tablets USP are affected?
- Distributed: Nationwide.. The recall covers these lots — Lot # QB00865, exp. date Feb 2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0227-2026.