FDA Recalls Desipramine Tablets Due to N-Nitroso Impurity
Heritage Pharmaceuticals is recalling Desipramine Hydrochloride 75 mg tablets nationwide due to manufacturing deviations resulting in N-Nitroso impurity exceeding acceptable levels. Patients should consult their pharmacist or doctor regarding their medication.
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 FDA Class II recall involves a manufacturing defect with N-Nitroso impurity exceeding permissible daily intake levels. No illnesses or injuries have been reported. The hazard poses a potential health risk, placing this in the High category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Heritage Pharmaceuticals Inc. is recalling Desipramine Hydrochloride Tablets, USP, 75 mg (100 count bottles) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because N-Nitroso Desipramine impurity was detected at levels exceeding the permissible acceptable daily intake.
The affected product was distributed nationwide. The recall involves 2,418 bottles with the following lot numbers: Lot 18036662 (expiration date 07/31/2026) and Lot 18037649 (expiration date 03/31/2027). The tablets are manufactured by USV Private Limited in Daman, India, for Avet Pharmaceuticals Inc. (which operates as Heritage Pharmaceuticals Inc.).
Patients currently taking this medication should contact their pharmacy or healthcare provider immediately to discuss whether they may have received affected product and what action to take. Do not stop taking the medication without consulting a healthcare professional.
The recalled product
- Product
- DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
- Brand
- DESIPRAMINE HYDROCHLORIDE
- Manufacturer
- Heritage Pharmaceuticals Inc
- 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 (3)
- Lot#: 18036662
- Exp. Date: 07/31/2026 Lot#: 18037649
- Exp. Date: 03/31/2027
UPCs (6)
- 0323155579017
- 0323155582017
- 0323155578010
- 0323155583250
- 0323155581010
- 0323155580013
Distribution
Distributed nationwide across the United States.
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- High
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