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- Recall Enforcement Event ID: 96194
Recall Enforment Report D-0236-2025
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 01-29-2025 for the product Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. The product was recalled due to cgmp deviations: presence of n-nitroso atomoxetine impurity above the fda recommended limit.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0236-2025 | 01-29-2025 | 02-26-2025 | Class II | 87,600 bottles | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0238-2025 | 01-29-2025 | 02-26-2025 | Class II | 120,000 bottles | 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. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0241-2025 | 01-29-2025 | 02-26-2025 | Class II | 233,040 bottles | 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. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0240-2025 | 01-29-2025 | 02-26-2025 | Class II | 133,824 bottles | 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. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0231-2025 | 01-29-2025 | 02-26-2025 | Class II | 70,032 bottles | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0232-2025 | 01-29-2025 | 02-26-2025 | Class II | 56,208 bottles | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0243-2025 | 01-29-2025 | 02-26-2025 | Class II | 58,416 bottles | 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. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0239-2025 | 01-29-2025 | 02-26-2025 | Class II | 119,040 bottles | 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. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0233-2025 | 01-29-2025 | 02-26-2025 | Class II | 175,920 bottles | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0234-2025 | 01-29-2025 | 02-26-2025 | Class II | 190,320 bottles | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0237-2025 | 01-29-2025 | 02-26-2025 | Class II | 39,168 bottles | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0235-2025 | 01-29-2025 | 02-26-2025 | Class II | 80,160 bottles | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0244-2025 | 01-29-2025 | 02-26-2025 | Class II | 58,368 bottles | 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. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
| D-0242-2025 | 01-29-2025 | 02-26-2025 | Class II | 53,952 bottles | 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. | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Ongoing |
Recalled Products
| NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
|---|---|---|---|---|---|---|
| 16714-755 | Atomoxetine | Atomoxetine | Capsule | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-756 | Atomoxetine | Atomoxetine | Capsule | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-757 | Atomoxetine | Atomoxetine | Capsule | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-758 | Atomoxetine | Atomoxetine | Capsule | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-759 | Atomoxetine | Atomoxetine | Capsule | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-760 | Atomoxetine | Atomoxetine | Capsule | Oral | Northstar Rx Llc | Human Prescription Drug |
| 16714-761 | Atomoxetine | Atomoxetine | Capsule | Oral | Northstar Rx Llc | Human Prescription Drug |
| 68462-265 | Atomoxetine | Atomoxetine | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-266 | Atomoxetine | Atomoxetine | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-267 | Atomoxetine | Atomoxetine | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-268 | Atomoxetine | Atomoxetine | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-269 | Atomoxetine | Atomoxetine | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-270 | Atomoxetine | Atomoxetine | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
| 68462-271 | Atomoxetine | Atomoxetine | Capsule | Oral | Glenmark Pharmaceuticals Inc., Usa | Human Prescription Drug |
Recall Enforcement Report D-0236-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0236-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 87,600 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- 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. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51
- Status
- Ongoing
Recall Enforcement Report D-0238-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0238-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 120,000 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01
- Status
- Ongoing
Recall Enforcement Report D-0241-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0241-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 233,040 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01
- Status
- Ongoing
Recall Enforcement Report D-0240-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0240-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 133,824 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- 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. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01
- Status
- Ongoing
Recall Enforcement Report D-0231-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0231-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 70,032 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51
- Status
- Ongoing
Recall Enforcement Report D-0232-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0232-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 56,208 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51
- Status
- Ongoing
Recall Enforcement Report D-0243-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0243-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 58,416 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01
- Status
- Ongoing
Recall Enforcement Report D-0239-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0239-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 119,040 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- 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. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01
- Status
- Ongoing
Recall Enforcement Report D-0233-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0233-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 175,920 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- 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. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51
- Status
- Ongoing
Recall Enforcement Report D-0234-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0234-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 190,320 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51
- Status
- Ongoing
Recall Enforcement Report D-0237-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0237-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 39,168 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51
- Status
- Ongoing
Recall Enforcement Report D-0235-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0235-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 80,160 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51
- Status
- Ongoing
Recall Enforcement Report D-0244-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0244-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 58,368 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01
- Status
- Ongoing
Recall Enforcement Report D-0242-2025
- Event ID
- 96194 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0242-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the U.S What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 53,952 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 02-26-2025
- Recall Initiation Date
- 01-29-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Code Info
- Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01
- Status
- Ongoing
