Desipramine 150 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 3,750 bottles of Desipramine Hydrochloride Tablets USP 150 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
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: Scored 3 under the risk-of-harm criterion: a named nitrosamine impurity exceeding its acceptable daily intake is a defined safety threshold breach, with no injuries reported.
Plain-English summary
Desipramine Hydrochloride Tablets, USP, 150 mg, in 50-count bottles, manufactured by USV Private Limited in Daman, India for Avet Pharmaceuticals of East Brunswick, New Jersey, are being recalled for CGMP deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
The recall covers 3,750 bottles from lot 18035739, which expired 30 November 2025, carrying NDC 23155-583-25. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record identifies the nitrosamine impurity and the exceeded intake level, and reports no injuries.
Desipramine is a prescription medicine, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
- Brand
- DESIPRAMINE HYDROCHLORIDE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug — Antidepressant
- Affected units
- 3,750
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#: 18035739
- Exp. Date: 11/30/2025
UPCs (6)
- 0323155579017
- 0323155582017
- 0323155578010
- 0323155583250
- 0323155581010
- 0323155580013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Heritage Pharmaceuticals 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 →Related recalls
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