May 2026 FDA Recall Duloxetine by Asclemed Usa Inc. (D-0555-2026 - CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.)
This Class II drug recall was voluntarily initiated by Asclemed Usa Inc. on May 14, 2026 for the product Duloxetine. The FDA reported the reason for recall as cgmp deviations; presence of nitrosamine drug substance related impurity (ndsri), n-nitroso-duloxetine, above the fda acceptable intake limit.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0555-2026
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
05-14-2026
06-10-2026
50 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Asclemed USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# 050725G-30 & 050725F-30, Exp Date: 06/30/2026
