Sertraline tablets recalled because bottle seals are not adhering
Lupin Pharmaceuticals is recalling 52,128 bottles of Sertraline Hydrochloride Tablets, 100 mg, over a defective container in which the seal is not adhering to the bottles.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a container seal defect with no stated clinical consequence or reported harm.
Plain-English summary
Sertraline Hydrochloride Tablets USP, 100 mg, in 90-tablet bottles, manufactured by Lupin Pharmaceuticals, Inc. of Naples, Florida, under NDC 68180-353-09, are being recalled.
The reason given in the enforcement record is a defective container: the seal is not adhering to the bottles.
The recall covers 52,128 bottles from lot QB00865, expiry February 2028. Distribution was nationwide. The FDA has classified the action as Class II.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
- Brand
- SERTRALINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antidepressant
- Affected units
- 52,128
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # QB00865
- exp. date Feb 2028
Distribution
Distributed nationwide across the United States.
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