Desipramine Hydrochloride Tablets Recalled for Excess N-Nitroso Impurity
Heritage Pharmaceuticals is recalling 8,754 bottles of Desipramine Hydrochloride Tablets nationwide due to N-Nitroso Desipramine 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: FDA Class II recall with no reported illnesses or injuries. The hazard is a chemical impurity (N-Nitroso Desipramine) exceeding regulatory limits, constituting a risk-of-harm scenario where injury has not yet been reported. This meets the rubric criterion for Score 3 (High).
Plain-English summary
Heritage Pharmaceuticals Inc is recalling certain lots of Desipramine Hydrochloride Tablets, USP, 25 mg, manufactured by USV Private Limited in Daman, India and distributed nationwide. Approximately 8,754 bottles are affected, including Lot 18035876 (expiration 12/31/2025) and Lot 18036909 (expiration 09/30/2026).
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation: the affected lots contain an N-Nitroso Desipramine impurity at levels exceeding the permissible acceptable daily intake limit. N-Nitroso compounds are controlled by the FDA as potentially harmful chemical impurities.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
- Brand
- DESIPRAMINE HYDROCHLORIDE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug
- Hazard
- n-nitroso-impurity
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#: 18035876
- Exp Date: 12/31/2025 Lot#: 18036909
- Exp Date: 09/30/2026
UPCs (6)
- 0323155579017
- 0323155582017
- 0323155578010
- 0323155583250
- 0323155581010
- 0323155580013
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DESIPRAMINE HYDROCHLORIDE
- HighDesipramine Hydrochloride Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-11-05
- HighDesipramine Hydrochloride Tablets Recalled for Elevated N-Nitroso Impurity
FDA (Drugs) · 2025-11-05
- High
- HighDesipramine Hydrochloride Tablets recalled for excess N-Nitroso impurity
FDA (Drugs) · 2025-11-05
- HighFDA Recalls Desipramine Tablets Due to N-Nitroso Impurity
FDA (Drugs) · 2025-11-05
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27