Desipramine Hydrochloride Tablets Recalled for N-Nitroso Impurity
Heritage Pharmaceuticals is recalling Desipramine Hydrochloride 150 mg tablets nationwide due to N-Nitroso impurity contamination exceeding acceptable safety levels. Affected patients should consult their healthcare provider.
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 involving a confirmed contamination (N-Nitroso impurity) that exceeds permissible safety thresholds. Although no illnesses or injuries have been reported, N-Nitroso compounds represent a known health risk, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Heritage Pharmaceuticals Inc is recalling Desipramine Hydrochloride Tablets, USP, 150 mg, due to the presence of N-Nitroso Desipramine impurity that exceeds the permissible acceptable daily intake level.
The recall affects 3,750 bottles distributed nationwide. The affected product is identified by Lot #18035739 with an expiration date of 11/30/2025. The tablets are manufactured by USV Private Limited in Daman, India, and distributed by Avet Pharmaceuticals Inc., East Brunswick, New Jersey.
Patients taking this medication should contact their healthcare provider or pharmacist immediately to determine if they have received an affected bottle and to discuss their medication options. Patients should not stop taking desipramine without medical guidance, as abrupt discontinuation can have serious health consequences.
The recalled product
- Product
- DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
- Brand
- DESIPRAMINE HYDROCHLORIDE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Hazard
- n-nitroso-impurity
- contamination
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.
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