NDC 76420-636

Duloxetine 40 mg capsule, delayed release

On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Ajanta Pharma USA Inc.'s NDC 27241-164.

Where the pills inside were made

Repackaging site

• Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it

Recalls

• May 14, 2026 · Class II · Asclemed USA Inc.
  CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
  Lots: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
• Apr 29, 2026 · Class II · Ajanta Pharma Ltd.
  CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
  Lots: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
• Apr 29, 2026 · Class II · Ajanta Pharma Ltd.
  CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
  Lots: Lot#: PA07434, Exp. May 2026.
• Apr 29, 2026 · Class II · Ajanta Pharma Ltd.
  CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
  Lots: Lot#: PA10734, Exp. Jun 2026.

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Duloxetine: every company that makes it

Form

capsule, delayed release, oral

Strength

40 mg

Approval

ANDA ANDA208706

On the market since

Mar 25, 2019

Package NDCs

76420-636-01 76420-636-20 76420-636-30 76420-636-60 76420-636-90

Official label

DailyMed (National Library of Medicine), updated Apr 3, 2025

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