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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Glenmark and Northstar Atomoxetine Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: February 20, 2025
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Summary

Glenmark Pharmaceuticals is recalling 1,476,048 bottles of Atomoxetine Capsules (atomoxetine) sold under the Glenmark and Northstar brands. This recall is due to the presence of an impurity called N-nitroso atomoxetine at levels exceeding those recommended by the FDA. If you use this medication to treat ADHD, speak with your doctor or pharmacist about these recalled batches.

Risk

N-nitroso atomoxetine is considered a probable human carcinogen, and long-term exposure above safety limits may increase the risk of developing cancer.

What You Should Do

  1. This recall affects various strengths of Atomoxetine Capsules, USP (10 mg to 100 mg), distributed nationwide under the Glenmark Pharmaceuticals and Northstar Rx LLC brands.
  2. To identify if your medication is affected, check the bottle label for the product name, strength, and the National Drug Code (NDC) which begins with either 68462 or 16714. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atomoxetine Capsules, USP (10 mg)by Glenmark
Variants: 10 mg, Glenmark
Lot Numbers:
19232368 (Exp. 5/2025)
19235088 (Exp. 11/2025)
19241447 (Exp. 3/2026)
19243146 (Exp. 7/2026)
NDC:
68462-265-30
Product: Atomoxetine Capsules, USP (18 mg)by Glenmark
Variants: 18 mg, Glenmark
Lot Numbers:
19233756 (Exp. 8/2025)
19235111 (Exp. 11/2025)
19242167 (Exp. 5/2026)
19242180 (Exp. 5/2026)
NDC:
68462-266-30
Product: Atomoxetine Capsules, USP (25 mg)by Glenmark
Variants: 25 mg, Glenmark
Lot Numbers:
19233792 (Exp. 8/2025)
19233795 (Exp. 8/2025)
19234258 (Exp. 9/2025)
19240912 (Exp. 2/2026)
19241476 (Exp. 3/2026)
19241477 (Exp. 3/2026)
19242599 (Exp. 6/2026)
19243163 (Exp. 7/2026)
19243162 (Exp. 7/2026)
19243884 (Exp. 9/2026)
19243887 (Exp. 9/2026)
NDC:
68462-267-30
Product: Atomoxetine Capsules, USP (40 mg)by Glenmark
Variants: 40 mg, Glenmark
Lot Numbers:
19234109 (Exp. 9/2025)
19234897 (Exp. 11/2025)
19240501 (Exp. 1/2026)
19241489 (Exp. 3/2026)
19241806 (Exp. 4/2026)
NDC:
68462-268-30
Product: Atomoxetine Capsules, USP (60 mg)by Glenmark
Variants: 60 mg, Glenmark
Lot Numbers:
19234630 (Exp. 10/2025)
19240528 (Exp. 1/2026)
19240529 (Exp. 1/2026)
NDC:
68462-269-30
Product: Atomoxetine Capsules, USP (80 mg)by Glenmark
Variants: 80 mg, Glenmark
Lot Numbers:
19234153 (Exp. 9/2025)
19234900 (Exp. 11/2025)
19234929 (Exp. 11/2025)
19240936 (Exp. 2/2026)
19240942 (Exp. 2/2026)
19243199 (Exp. 7/2026)
19243190 (Exp. 7/2026)
19244013 (Exp. 9/2026)
19244014 (Exp. 9/2026)
NDC:
68462-270-30
Product: Atomoxetine Capsules, USP (100 mg)by Glenmark
Variants: 100 mg, Glenmark
Lot Numbers:
19234955 (Exp. 11/2025)
19234956 (Exp. 11/2025)
19240971 (Exp. 2/2026)
19241864 (Exp. 4/2026)
NDC:
68462-271-30
Product: Atomoxetine Capsules, USP (10 mg)by Northstar
Variants: 10 mg, Northstar
Lot Numbers:
19232356 (Exp. 5/2025)
19233198 (Exp. 7/2025)
19234213 (Exp. 9/2025)
19234232 (Exp. 9/2025)
19241445 (Exp. 3/2026)
19243033 (Exp. 7/2026)
19243121 (Exp. 7/2026)
NDC:
16714-755-01
Product: Atomoxetine Capsules, USP (18 mg)by Northstar
Variants: 18 mg, Northstar
Lot Numbers:
19233228 (Exp. 7/2025)
19233227 (Exp. 7/2025)
19233757 (Exp. 8/2025)
19234229 (Exp. 9/2025)
19235090 (Exp. 11/2025)
19241471 (Exp. 3/2026)
19242180 (Exp. 5/2026)
NDC:
16714-756-01
Product: Atomoxetine Capsules, USP (25 mg)by Northstar
Variants: 25 mg, Northstar
Lot Numbers:
19232506 (Exp. 5/2025)
19232397 (Exp. 5/2025)
19232415 (Exp. 5/2025)
19233791 (Exp. 8/2025)
19234248 (Exp. 9/2025)
19240909 (Exp. 2/2026)
19242598 (Exp. 6/2026)
19243163 (Exp. 7/2026)
19243122 (Exp. 7/2026)
19243884 (Exp. 9/2026)
NDC:
16714-757-01
Product: Atomoxetine Capsules, USP (40 mg)by Northstar
Variants: 40 mg, Northstar
Lot Numbers:
19232540 (Exp. 5/2025)
19232524 (Exp. 5/2025)
19232553 (Exp. 5/2025)
19240510 (Exp. 1/2026)
19241489 (Exp. 3/2026)
19243905 (Exp. 9/2026)
19243935 (Exp. 9/2026)
NDC:
16714-758-01
Product: Atomoxetine Capsules, USP (60 mg)by Northstar
Variants: 60 mg, Northstar
Lot Numbers:
19234630 (Exp. 10/2025)
19240529 (Exp. 1/2026)
NDC:
16714-759-01
Product: Atomoxetine Capsules, USP (80 mg)by Northstar
Variants: 80 mg, Northstar
Lot Numbers:
19233234 (Exp. 7/2025)
19233253 (Exp. 7/2025)
19234154 (Exp. 9/2025)
19243185 (Exp. 7/2026)
19243951 (Exp. 9/2026)
19243974 (Exp. 9/2026)
NDC:
16714-760-01
Product: Atomoxetine Capsules, USP (100 mg)by Northstar
Variants: 100 mg, Northstar
Lot Numbers:
19233270 (Exp. 7/2025)
19233278 (Exp. 7/2025)
19233285 (Exp. 7/2025)
19233806 (Exp. 8/2025)
19240954 (Exp. 2/2026)
19241854 (Exp. 4/2026)
NDC:
16714-761-01

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96194
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies nationwide
Manufactured In: India
Units Affected: 14 products (70,032 bottles; 56,208 bottles; 175,920 bottles; 190,320 bottles; 80,160 bottles; 87,600 bottles; 39,168 bottles; 120,000 bottles; 119,040 bottles; 133,824 bottles; 233,040 bottles; 53,952 bottles; 58,416 bottles; 58,368 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.