US Drug Recall Register
Class III · Low risk Terminated Initiated Jul 16, 2015 (11 years ago)

Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual…

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

Why it was recalled

Chemical Contamination; benzophenone leached from the product label varnish

What was recalled

Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01

Recalling firm
Mutual Pharmaceutical Company, Inc.
NDC code
54738-912-01
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1423-2015

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.

Other Imipramine recalls

See all