Desipramine antidepressant tablets recalled due to manufacturing impurity exceeding safety limits
Heritage Pharmaceuticals recalls 5,880 bottles of desipramine tablets due to a chemical impurity from manufacturing that exceeds the 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: This qualifies as a risk-of-harm product where injury has not yet been reported. The tablets contain N-nitroso desipramine impurity exceeding the acceptable daily intake level, creating a documented chemical hazard, though no illnesses or injuries have been reported to the FDA.
Plain-English summary
Heritage Pharmaceuticals Inc is recalling 5,880 bottles of Desipramine Hydrochloride Tablets, USP, 50 mg (NDC 23155-580-01, Lot #18036713, expiration 08/31/2026).
The recall is due to a current good manufacturing practice (CGMP) deviation: the tablets contain N-nitroso desipramine impurity that exceeds the permissible acceptable daily intake level. The FDA has classified this recall as Class II.
The affected tablets were distributed nationwide in the United States.
Patients who have this medication should consult their healthcare provider or pharmacist about the recall. Do not use the product. Contact Heritage Pharmaceuticals for instructions on disposal or return of the affected medication.
The recalled product
- Product
- DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
- Brand
- DESIPRAMINE HYDROCHLORIDE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug
- Hazard
- n-nitroso-impurity
- manufacturing-defect
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#:18036713
- Exp Date: 08/31/2026
UPCs (6)
- 0323155579017
- 0323155582017
- 0323155578010
- 0323155583250
- 0323155581010
- 0323155580013
Distribution
Distributed nationwide across the United States.
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