CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Desipramine Hydrochloride Tablets, USP, 25 mg bottle recalled
Heritage Pharmaceuticals is recalling Desipramine Hydrochloride Tablets, USP, 25 mg bottle (, distributed nationwide in the US. The recall was initiated on 6 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0108-2026
- FDA event ID
- 97770
- Recalling firm
- Heritage Pharmaceuticals, East Brunswick, NJ
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Oct 2025
- FDA classified
- 27 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 6 Oct 2025 | Recall initiated by company | |
| 27 Oct 2025 | Classified by FDA | +21 days |
| 5 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Which lots are affected?
Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97770| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Desipramine Hydrochloride Tablets, USP, 150 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
More recalls from Heritage Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate Hydrochloride | Heritage Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Desipramine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 150 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |