Duloxetine DR Capsules recall
FDA recall D-0555-2026 · initiated May 14, 2026
Asclemed USA Inc. recalled Duloxetine DR Capsules in May 2026 — an FDA Class II recall (D-0555-2026) because CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
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: 50 bottles
Details
- Product
- Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
- Recalling company
- Asclemed USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 14, 2026
- FDA report date
- Jun 10, 2026
Frequently asked
- Was Duloxetine DR Capsules recalled?
- Asclemed USA Inc. recalled Duloxetine DR Capsules in May 2026 — an FDA Class II recall (D-0555-2026) because CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine DR Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0555-2026 was: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
- Is a recalled Duloxetine DR Capsules 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 Duloxetine DR Capsules are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026. 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-0555-2026.