Desipramine 100 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets USP 100 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, 100 mg, in 100-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 5,882 bottles from lot 18035574 (which expired 31 October 2025) and lot 18036758 (expiring 31 August 2026), carrying NDC 23155-582-01. 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 an 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
- Hazard
- nitrosamine
- impurity
- cgmp-deviation
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.
Related recalls
Same brand · DESIPRAMINE HYDROCHLORIDE
- HighDesipramine tablets recalled over nitrosamine impurity above acceptable daily intake
FDA (Drugs) · 2025-11-05
- HighDesipramine 50 mg tablets recalled over nitrosamine impurity above intake limit
FDA (Drugs) · 2025-11-05
- HighDesipramine 150 mg tablets recalled over nitrosamine impurity above intake limit
FDA (Drugs) · 2025-11-05
- HighDesipramine 25 mg tablets recalled over nitrosamine impurity above intake limit
FDA (Drugs) · 2025-11-05
- HighDesipramine 75 mg tablets recalled over nitrosamine impurity above intake limit
FDA (Drugs) · 2025-11-05
Same category
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22