Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Desipramine Hydrochloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Affected NDC
23155-0581-01
Compare with the code on your package — it is the most precise check available.
Drug: Desipramine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Desipramine Hydrochloride NDC 23155-0581 |
75 mg/1 | Tablet Oral |
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | Rx |
- Recalling firm
- Heritage Pharmaceuticals Inc
- NDC code
- 23155-581-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0110-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Desipramine recalls
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Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Other recalls by Heritage Pharmaceuticals Inc
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Class II · Moderate risk
Clindamycin Palmitate Hydrochloride for Oral Solution
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk
Desipramine Hydrochloride Tablets
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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