The Recall Desk
HighFDA (Drugs)·D-0555-2026·Announced 2026-06-10

Enovachem duloxetine capsules exceed the nitrosamine acceptable intake limit

Duloxetine DR Capsules, 30 mg, relabeled by Enovachem are being recalled over CGMP deviations and N-nitroso-duloxetine above the FDA acceptable intake limit.

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 for a nitrosamine impurity above its acceptable intake limit, a product-quality failure creating risk of harm with no injuries reported.

Plain-English summary

Duloxetine DR Capsules, 30 mg, in 30-count bottles, relabeled by Enovachem Pharmaceuticals of Torrance, California and marketed by Ajanta Pharma USA Inc., NDC 76420-634-30, are being recalled. The action covers 50 bottles.

The stated reasons are current good manufacturing practice deviations and the presence of a Nitrosamine Drug Substance Related Impurity, N-nitroso-duloxetine, above the FDA acceptable intake limit. Nitrosamine impurities are controlled to defined intake limits because of their potential for long-term harm. The FDA classified the action as Class II.

Affected lots are 050725G-30 and 050725F-30, expiry 06/30/2026. Distribution was US nationwide.

This is a prescription medicine. Patients should not stop taking a prescribed course without medical advice; anyone holding an affected lot should contact their pharmacy or prescriber about a replacement supply.

The recalled product

Product
DULOXETINE (DULOXETINE)
Brand
DULOXETINE
Manufacturer
Asclemed USA Inc.
Category
Drug — Delayed-release capsule
Hazard
  • nitrosamine-impurity
  • cgmp-deviation
  • above-daily-limit
  • class-ii
  • prescription-drug

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 (2)

  • Lot # 050725G-30 & 050725F-30
  • Exp Date: 06/30/2026

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · DULOXETINE

Same category