Atomoxetine Capsule
FDA Recall NDC 16714-757
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 7 recorded enforcement report(s) associated with Atomoxetine (NDC 16714-757). A significant event, classified as Class II, was initiated on Jan 29, 2025 by Northstar Rx Llc. The reported reason for this action was: "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit."
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 Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
53,952 bottles
Recall Profile & Regulatory Data
Event ID
96194
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026.
Affected Packages Involved in this Recall
16714-755-01Product
16714-756-01Product
16714-757-01Product
16714-758-01Product
16714-759-01Product
16714-760-01Product
16714-761-01Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
119,040 bottles
Recall Profile & Regulatory Data
Event ID
96194
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026.
Affected Packages Involved in this Recall
16714-755-01Product
16714-756-01Product
16714-757-01Product
16714-758-01Product
16714-759-01Product
16714-760-01Product
16714-761-01Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
120,000 bottles
Recall Profile & Regulatory Data
Event ID
96194
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026.
Affected Packages Involved in this Recall
16714-755-01Product
16714-756-01Product
16714-757-01Product
16714-758-01Product
16714-759-01Product
16714-760-01Product
16714-761-01Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
233,040 bottles
Recall Profile & Regulatory Data
Event ID
96194
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026.
Affected Packages Involved in this Recall
16714-755-01Product
16714-756-01Product
16714-757-01Product
16714-758-01Product
16714-759-01Product
16714-760-01Product
16714-761-01Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
58,416 bottles
Recall Profile & Regulatory Data
Event ID
96194
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.
Affected Packages Involved in this Recall
16714-755-01Product
16714-756-01Product
16714-757-01Product
16714-758-01Product
16714-759-01Product
16714-760-01Product
16714-761-01Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
58,368 bottles
Recall Profile & Regulatory Data
Event ID
96194
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026.
Affected Packages Involved in this Recall
16714-755-01Product
16714-756-01Product
16714-757-01Product
16714-758-01Product
16714-759-01Product
16714-760-01Product
16714-761-01Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
133,824 bottles
Recall Profile & Regulatory Data
Event ID
96194
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.
Affected Packages Involved in this Recall
16714-755-01Product
16714-756-01Product
16714-757-01Product
16714-758-01Product
16714-759-01Product
16714-760-01Product
16714-761-01Product
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.
