Desipramine Hydrochloride Tablets recall
FDA recall D-0108-2026 · initiated Oct 6, 2025
Heritage Pharmaceuticals Inc recalled Desipramine Hydrochloride Tablets in Oct 2025 — an FDA Class II recall (D-0108-2026) because CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8,754 bottles.
Details
- Product
- 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.
- Recalling company
- Heritage Pharms Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Oct 6, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was Desipramine Hydrochloride Tablets recalled?
- Heritage Pharmaceuticals Inc recalled Desipramine Hydrochloride Tablets in Oct 2025 — an FDA Class II recall (D-0108-2026) because CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Desipramine Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0108-2026 was: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
- Is a recalled Desipramine Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Desipramine Hydrochloride Tablets are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0108-2026.