Desipramine Hydrochloride Tablets recalled for excess N-Nitroso impurity
Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets nationwide due to N-Nitroso impurity exceeding acceptable daily intake limits.
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 of a prescription antidepressant due to N-Nitroso impurity exceeding acceptable daily intake levels. Although no illnesses or injuries have been reported, the recall meets the rubric criterion for High severity: a risk-of-harm pharmaceutical product where injury has not yet been reported.
Plain-English summary
Heritage Pharmaceuticals Inc is recalling Desipramine Hydrochloride Tablets, USP, 100 mg due to N-Nitroso Desipramine impurity exceeding acceptable daily intake limits. The impurity was identified as a manufacturing quality deviation.
The recall affects 5,882 bottles distributed nationwide. Affected lots include Lot 18035574 (expires 10/31/2025) and Lot 18036758 (expires 08/31/2026). The tablets are manufactured by USV Private Limited in Daman, India, for Avet Pharmaceuticals Inc. in New Jersey and distributed by Heritage Pharmaceuticals Inc.
No illnesses or injuries have been reported in connection with this recall. Patients currently taking this medication should consult their healthcare provider or pharmacist regarding their prescription. Healthcare providers and pharmacists should stop distribution of the affected lots and quarantine remaining inventory.
The recalled product
- Product
- DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
- Brand
- DESIPRAMINE HYDROCHLORIDE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug
- Hazard
- n-nitroso-impurity
- pharmaceutical-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 (3)
- Lot#: 18035574
- Exp. Date 10/31/2025 Lot#: 18036758
- Exp. Date 08/31/2026
UPCs (6)
- 0323155579017
- 0323155582017
- 0323155578010
- 0323155583250
- 0323155581010
- 0323155580013
Distribution
Distributed nationwide across the United States.
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- High
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