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Drug FDA Class II Ongoing Quality

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

Lupin Pharmaceuticals Inc. Published Dec 17, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Defective container - seal not adhering to bottles

Affected products (1)

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

SERTRALINE HYDROCHLORIDE · 52,128 bottles

NDC: 68180-351, 68180-352, 68180-353, 68180-978, 68180-986, 68180-992, 68180-351-08, 68180-351-06, 68180-351-09, 68180-351-03, 68180-351-01, 68180-352-11, 68180-352-01, 68180-352-03, 68180-352-06, 68180-352-09, 68180-352-02, 68180-352-05, 68180-353-11, 68180-353-01, 68180-353-03, 68180-353-02, 68180-353-06, 68180-353-09, 68180-353-05, 68180-978-01, 68180-978-02, 68180-978-03, 68180-986-04, 68180-986-02, 68180-986-01, 68180-986-03, 68180-992-04, 68180-992-01, 68180-992-02, 68180-992-03
Lot codes: QB00865
Code info: Lot # QB00865, exp. date Feb 2028

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 5, 2025
  2. Published
    Dec 17, 2025
Recall number
D-0227-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.