NDC 68788-7672

Duloxetine 60 mg capsule, delayed release

On the label: Preferred Pharmaceuticals, Inc... It's repackaged: Preferred Pharmaceuticals, Inc.. rebottles it from Ajanta Pharma USA Inc.'s NDC 27241-099.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Ajanta Pharma Limited	Chhatrapati Sambhajinagar, India	Makes it	Problems found, fixed voluntarilyApr 21, 2026 · 6 inspections
Ajanta Pharma Limited	Bharuch, India	Makes it	No problems foundJun 23, 2023 · 3 inspections

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.

Generic drug: Duloxetine: every company that makes it
Form: capsule, delayed release, oral
Strength: 60 mg
Approval: ANDA ANDA208706
On the market since: Feb 28, 2020
Package NDCs: 68788-7672-0 68788-7672-1 68788-7672-2 68788-7672-3 68788-7672-6 68788-7672-8 68788-7672-9
Official label: DailyMed (National Library of Medicine), updated Apr 4, 2025

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