Class II U.S. Food and Drug Administration

Lupin Pharmaceuticals Inc. Sertraline Hydrochloride Tablets USP, 100 mg recall: Defective container - seal not adhering to bottles

Recall published 10 months ago

Defective container - seal not adhering to bottles

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Defective container - seal not adhering to bottles

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0227-2026
Published
December 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Lupin Pharmaceuticals Inc.
Product type
Prescription & OTC drugs
Units affected
52,128 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot # QB00865, exp. date Feb 2028

Products covered by this recall

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • QB00865
  • 128 bottles

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Feb 2028 — 52
  • 128 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 68180-353-09

Package size

Match the net weight or the piece count on the front of the pack.

  • 100 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Lupin Pharmaceuticals Inc. — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Report side effects you think the product caused to FDA MedWatch.
  3. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  4. Ask the dispensing pharmacy for a replacement from an unaffected lot.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Lupin Pharmaceuticals Inc. — 5801 Pelican Bay Blvd, Naples, FL, 34108-2755

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Lupin Pharmaceuticals Inc. prescription & otc drugs recalled?

Defective container - seal not adhering to bottles Defective container - seal not adhering to bottles

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code QB00865, 128 bottles; best-by date Feb 2028 — 52 or 128 bottles. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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