Sertraline Hydrochloride Tablet, Film Coated
FDA Recall NDC 68180-992
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sertraline Hydrochloride (NDC 68180-992). A significant event, classified as Class II, was initiated on Nov 05, 2025 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Defective container - seal not adhering to bottles"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
November 2025 Class II Recall: Defective container - seal not adhering to bottles
Recall Number
Class II Ongoing
Defective container - seal not adhering to bottles
Nov 05, 2025
Dec 17, 2025
52,128 bottles
Recall Profile & Regulatory Data
Event ID
97936
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Product Description
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Batch or Lot Expiration Information
Lot# QB00865, exp. date Feb 2028
Affected Packages Involved in this Recall
68180-351-08Product
68180-351-06Product
68180-351-09Product
68180-351-03Product
68180-351-01Product
68180-352-11Product
68180-352-01Product
68180-352-03Product
68180-352-06Product
68180-352-09Product
68180-352-02Product
68180-352-05Product
68180-353-11Product
68180-353-01Product
68180-353-03Product
68180-353-02Product
68180-353-06Product
68180-353-09Product
68180-353-05Product
68180-978-01Product
68180-978-02Product
68180-978-03Product
68180-986-04Product
68180-986-02Product
68180-986-01Product
68180-986-03Product
68180-992-04Product
68180-992-01Product
68180-992-02Product
68180-992-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
