Desipramine Hydrochloride Tablets Recalled for Elevated N-Nitroso Impurity
Heritage Pharmaceuticals is recalling Desipramine Hydrochloride 10 mg tablets due to N-Nitroso Desipramine impurity exceeding safe intake limits. The affected lot was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. However, it involves an impurity (N-Nitroso Desipramine) exceeding the permissible acceptable daily intake level, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Heritage Pharmaceuticals Inc is recalling Desipramine Hydrochloride Tablets, USP, 10 mg, supplied in 100-count bottles. The recalled product was manufactured by USV Private Limited in Daman, India, and distributed by Heritage Pharmaceuticals Inc and Avet Pharmaceuticals Inc.
The recall was initiated due to manufacturing deviations that resulted in Desipramine Hydrochloride tablets containing N-Nitroso Desipramine impurity levels exceeding the permissible acceptable daily intake limit.
The affected product (Lot 18036908, expiration date 09/30/2026) was distributed nationwide across the United States. Approximately 6,979 bottles have been recalled.
Patients taking this medication should contact their healthcare provider or pharmacist for guidance. Do not discontinue use without medical advice. Return any affected product to the pharmacy for proper disposal.
The recalled product
- Product
- DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
- Brand
- DESIPRAMINE HYDROCHLORIDE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug
- Hazard
- n-nitroso-impurity
- carcinogen
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 (2)
- Lot#: 18036908
- Exp. Date: 09/30/2026
UPCs (6)
- 0323155579017
- 0323155582017
- 0323155578010
- 0323155583250
- 0323155581010
- 0323155580013
Distribution
Distributed nationwide across the United States.
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