US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 8, 2021 (5 years ago)

Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Out of specification result observed in a dissolution test at the 9-month long term stability time point.

What was recalled

Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06

Recalling firm
Lupin Pharmaceuticals Inc.
NDC code
68180-316-06
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0027-2022

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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