The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1425-2015·Announced 2015-09-16

Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination

Mutual Pharmaceutical is recalling Imipramine HCl tablets because benzophenone leached from the label varnish. The recall covers 10,080 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard involves chemical contamination from label varnish, which is a minor labeling/packaging-related issue without reported injuries.

Plain-English summary

Mutual Pharmaceutical Company, Inc. is recalling 10,080 bottles of Imipramine HCl Tablets, USP, 50 mg, 100 count. The recall is due to chemical contamination, specifically benzophenone leaching from the product label varnish.

The affected product is identified by NDC 54738-914-01. The recall includes lots 6671901 (exp 12/16), 6679901 (exp 2/17), 6694201 (exp 5/17), 6697901 (exp 6/17), and 6704201 (exp 7/17). The product was distributed nationwide.

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
Manufacturer
Mutual Pharmaceutical Company, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
10,080

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Mutual Pharmaceutical Company, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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