Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Benzophenone Contamination
Mutual Pharmaceutical is recalling 5,472 bottles of Imipramine HCl 10 mg tablets because benzophenone leached from the label varnish.
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 the use of or exposure to the product is not likely to cause adverse health consequences. The hazard is a chemical contamination (benzophenone) without reported injuries or illnesses.
Plain-English summary
Mutual Pharmaceutical Company, Inc. is recalling 5,472 bottles of Imipramine HCl Tablets, USP, 10 mg, 100 count bottles (NDC 54738-912-01). The recall is due to chemical contamination where benzophenone leached from the product label varnish.
The affected lots are #6671801 (expiration 12/16) and #6706401 (expiration 7/17). The product was distributed nationwide. This is a prescription-only medication.
Consumers with these specific lot numbers should stop using the product and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
- Manufacturer
- Mutual Pharmaceutical Company, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 5,472
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 (3)
- lot #s 6671801
- exp 12/16 and 6706401
- 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.
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