Atomoxetine Capsule
FDA Recall NDC 68462-271
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 68462-271). A significant event, classified as Class II, was initiated on Jan 29, 2025 by Glenmark Pharmaceuticals Inc., Usa. 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
56,208 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: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026.
Affected Packages Involved in this Recall
68462-265-30Product
68462-265-23Product
68462-266-30Product
68462-266-23Product
68462-267-30Product
68462-267-23Product
68462-268-30Product
68462-268-23Product
68462-269-30Product
68462-269-23Product
68462-270-30Product
68462-270-23Product
68462-271-30Product
68462-271-51Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
87,600 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: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19234153, Exp.: 9/2025; 19234900, 19234929, Exp.: 11/2025; 19240936, 19240942, Exp.: 2/2026; 19243199, 19243190, Exp.:7/2026; 19244013, 19244014, Exp.: 9/2026.
Affected Packages Involved in this Recall
68462-265-30Product
68462-265-23Product
68462-266-30Product
68462-266-23Product
68462-267-30Product
68462-267-23Product
68462-268-30Product
68462-268-23Product
68462-269-30Product
68462-269-23Product
68462-270-30Product
68462-270-23Product
68462-271-30Product
68462-271-51Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
70,032 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: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.
Affected Packages Involved in this Recall
68462-265-30Product
68462-265-23Product
68462-266-30Product
68462-266-23Product
68462-267-30Product
68462-267-23Product
68462-268-30Product
68462-268-23Product
68462-269-30Product
68462-269-23Product
68462-270-30Product
68462-270-23Product
68462-271-30Product
68462-271-51Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
175,920 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: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.
Affected Packages Involved in this Recall
68462-265-30Product
68462-265-23Product
68462-266-30Product
68462-266-23Product
68462-267-30Product
68462-267-23Product
68462-268-30Product
68462-268-23Product
68462-269-30Product
68462-269-23Product
68462-270-30Product
68462-270-23Product
68462-271-30Product
68462-271-51Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
190,320 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: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.
Affected Packages Involved in this Recall
68462-265-30Product
68462-265-23Product
68462-266-30Product
68462-266-23Product
68462-267-30Product
68462-267-23Product
68462-268-30Product
68462-268-23Product
68462-269-30Product
68462-269-23Product
68462-270-30Product
68462-270-23Product
68462-271-30Product
68462-271-51Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
80,160 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: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026.
Affected Packages Involved in this Recall
68462-265-30Product
68462-265-23Product
68462-266-30Product
68462-266-23Product
68462-267-30Product
68462-267-23Product
68462-268-30Product
68462-268-23Product
68462-269-30Product
68462-269-23Product
68462-270-30Product
68462-270-23Product
68462-271-30Product
68462-271-51Product
Class II Ongoing
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Jan 29, 2025
Feb 26, 2025
39,168 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: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026.
Affected Packages Involved in this Recall
68462-265-30Product
68462-265-23Product
68462-266-30Product
68462-266-23Product
68462-267-30Product
68462-267-23Product
68462-268-30Product
68462-268-23Product
68462-269-30Product
68462-269-23Product
68462-270-30Product
68462-270-23Product
68462-271-30Product
68462-271-51Product
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.
