Duloxetine Capsule, Delayed Release
FDA Recall NDC 27241-099
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Duloxetine (NDC 27241-099). A significant event, classified as Class II, was initiated on Apr 29, 2026 by Ajanta Pharma Usa Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Apr 29, 2026
May 13, 2026
312,894 packs
Recall Profile & Regulatory Data
Event ID
98785
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ajanta Pharma Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within U.S
Product Description
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
Batch or Lot Expiration Information
Lot# : a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
Affected Packages Involved in this Recall
27241-097-06Product
27241-097-10Product
27241-097-90Product
27241-097-05Product
27241-098-03Product
27241-098-09Product
27241-098-10Product
27241-164-30Product
27241-099-03Product
27241-099-90Product
27241-099-40Product
Class II Ongoing
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.
Apr 29, 2026
May 13, 2026
117,168 packs
Recall Profile & Regulatory Data
Event ID
98785
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ajanta Pharma Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within U.S
Product Description
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Batch or Lot Expiration Information
Lot# : PA10734, Exp. Jun 2026.
Affected Packages Involved in this Recall
27241-097-06Product
27241-097-10Product
27241-097-90Product
27241-097-05Product
27241-098-03Product
27241-098-09Product
27241-098-10Product
27241-164-30Product
27241-099-03Product
27241-099-90Product
27241-099-40Product
Class II Ongoing
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.
Apr 29, 2026
May 13, 2026
77,376 packs.
Recall Profile & Regulatory Data
Event ID
98785
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ajanta Pharma Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within U.S
Product Description
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Batch or Lot Expiration Information
Lot# : PA07434, Exp. May 2026.
Affected Packages Involved in this Recall
27241-097-06Product
27241-097-10Product
27241-097-90Product
27241-097-05Product
27241-098-03Product
27241-098-09Product
27241-098-10Product
27241-164-30Product
27241-099-03Product
27241-099-90Product
27241-099-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
