November 2025 FDA Recall Sertraline Hydrochloride by Lupin Pharmaceuticals Inc.
D-0227-2026 - Defective container - seal not adhering to bottles
This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on November 5, 2025 for the product Sertraline Hydrochloride. The FDA reported the reason for recall as defective container - seal not adhering to bottles. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0227-2026
Defective container - seal not adhering to bottles
11-05-2025
12-17-2025
52,128 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
