HIGH

Lupin Pharmaceuticals Recalls Sertraline Hydrochloride Tablets for Defective Seal

Lupin Pharmaceuticals recalled 52,128 bottles of Sertraline Hydrochloride Tablets on November 5, 2025. Consumers reported issues with defective seals that do not adhere to the bottles. The recall follows a Class II classification due to potential contamination risks.

Quick Facts at a Glance

Recall Date
November 5, 2025
Hazard Level
HIGH
Brands
SERTRALINE HYDROCHLORIDE, Lupin Pharmaceuticals, Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Defective container - seal not adhering to bottles

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recall involves Sertraline Hydrochloride Tablets USP, 100 mg, in 90-tablet bottles. Lot number QB00865 with an expiration date of February 2028 is affected. The product was distributed nationwide.

The Hazard

The defective container seal may lead to contamination of the tablets. This poses a high hazard risk as it could compromise medication safety.

Reported Incidents

There have been no reported injuries or adverse incidents directly linked to this defect. However, the risk of contamination remains a concern.

What to Do

Stop using the product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance regarding the recall.

Contact Information

For more details, visit the FDA's recall page or contact Lupin Pharmaceuticals directly at their customer service number.

Key Facts

  • Recall date: November 5, 2025
  • Quantity recalled: 52,128 bottles
  • Lot number: QB00865, exp. date: Feb 2028
  • Class II recall due to high hazard risk

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot # QB00865
exp. date Feb 2028
UPC Codes
68180-351
68180-352
68180-353
+13 more
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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