US Drug Recall Register
Class III · Low risk Terminated Initiated Jun 22, 2017 (9 years ago)

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.

What was recalled

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06

Recalling firm
Lupin Pharmaceuticals Inc.
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0974-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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