CLASS III Drug recall · Reported 16 Sep 2015 · FDA Enforcement Report

Imipramine HCl Tablets, USP, 50 mg recalled

Mutual Pharmaceutical is recalling Imipramine HCl Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 16 Jul 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codeslots# 6671901, exp 12/16, 6679901, exp 2/17, 6694201, exp 5/17, 6697901, exp 6/17 and 6704201, exp 7/17

Quantity recalled10,080 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1425-2015
FDA event ID: 71836
Recalling firm: Mutual Pharmaceutical, Philadelphia, PA
Classification: Class III
Status: Terminated
Recall initiated: 16 Jul 2015
FDA classified: 9 Sep 2015
Reported: 16 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons

Timeline

16 Jul 2015	Recall initiated by company
9 Sep 2015	Classified by FDA	+55 days
16 Sep 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Chemical Contamination; benzophenone leached from the product label varnish

Product as listed by the FDA

Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Chemical Contamination; benzophenone leached from the product label varnish

Which lots are affected?

lots# 6671901, exp 12/16, 6679901, exp 2/17, 6694201, exp 5/17, 6697901, exp 6/17 and 6704201, exp 7/17

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 71836

This product is part of a recall event; the main page for the event is Felodipine Extended-Release Tablets, 2.5 mg recalled.

Reported	Class	Recall	Company	Reason	Where
16 Sep 2015	CLASS III	Felodipine Extended-Release Tablets, 2.5 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015	CLASS III	Felodipine Extended-Release Tablets, 10 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015	CLASS III	Felodipine Extended-Release Tablets, 5 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015	CLASS III	Imipramine HCl Tablets, USP, 25 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015	CLASS III	Imipramine HCl Tablets, USP, 10 mg recalled	Mutual Pharmaceutical	Other	Nationwide

More recalls from Mutual Pharmaceutical

All 14

Reported	Class	Recall	Company	Reason	Where
27 Jan 2016Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalled	Mutual Pharmaceutical	Other	MS
16 Sep 2015Drug	CLASS III	Imipramine HCl Tablets, USP, 10 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015Drug	CLASS III	Imipramine HCl Tablets, USP, 25 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015Drug	CLASS III	Felodipine Extended-Release Tablets, 5 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015Drug	CLASS III	Felodipine Extended-Release Tablets, 10 mg recalled	Mutual Pharmaceutical	Other	Nationwide

Other Imipramine recalls

All 4

Reported	Class	Recall	Company	Reason	Where
16 Sep 2015Drug	CLASS III	Imipramine HCl Tablets, USP, 10 mg recalled	Mutual Pharmaceutical	Other	Nationwide
16 Sep 2015Drug	CLASS III	Imipramine HCl Tablets, USP, 25 mg recalled	Mutual Pharmaceutical	Other	Nationwide
29 Jan 2014Drug	CLASS II	Imipramine HCL, Tablet, 25 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states