Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,
Summary
The FDA issued a Class II for Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manuf by Lupin Pharmaceuticals Inc.. Reason: Defective container - seal not adhering to bottles.
Details
Source
Drug Recall
External ID
D-0227-2026
Action Date
2025-12-17
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot # QB00865, exp. date Feb 2028
Quantity Affected: 52,128 bottles
Reason for Recall
Defective container - seal not adhering to bottles
Distribution
Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-05
Company
Naples, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 54 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lupin Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lupin Pharmaceuticals Inc. have FDA actions?
Lupin Pharmaceuticals Inc. has 49 FDA actions in our database, including 49 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0227-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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