Glenmark Atomoxetine Capsules Recall: N-Nitroso Impurity Risk
Glenmark recalls 80mg Atomoxetine Capsules due to N-Nitroso impurity exceeding FDA limits. Affected lots from 19234153 to 19244014 with specific expiration dates. No remedy stated in recall notice.
Recall notice
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Contact the company
What happened, in plain English
Glenmark is recalling 80mg Atomoxetine capsules that may contain an impurity exceeding FDA safety limits. This could pose a health risk, though the recall does not specify a remedy. Read more at govinfonow.com/recall/32302-glenmark-atomoxetine-capsules-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32302-glenmark-atomoxetine-capsules-recall-n-nitroso-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0236-2025
Cite this page
“Glenmark Atomoxetine Capsules Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32302-glenmark-atomoxetine-capsules-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0236-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0236-2025%22&limit=1).
Why it’s dangerous
The capsules contain N-Nitroso Atomoxetine impurities above the FDA's recommended limit. This impurity could potentially cause health issues, though the exact risk level is not specified in the recall.
Who’s affected
Prescription users of Atomoxetine capsules in the US. Those with the specific lot numbers and expiration dates listed are most at risk.
How to tell if you have this one
Check the lot number on the capsule bottle label. Affected lots include 19234153 (exp. 9/2025), 19234900, 19234929 (exp. 11/2025), and others with specific expiration dates listed in the recall.
- Brand
Glenmark- Category
Drug
All 14 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the U.S
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0231-2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.; Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026. | 70,032 bottles | 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 |
| D-0232-2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.; Lot Numbers: 19233756, Exp.: 8/2025; 19235111, Exp.: 11/2025; 19242167, Exp.: 5/2026; 19242180, Exp.: 5/2026. | 56,208 bottles | 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 |
| D-0233-2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.; 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. | 175,920 bottles | 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 |
| D-0234-2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.; Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026. | 190,320 bottles | 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 |
| D-0235-2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.; Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026. | 80,160 bottles | 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 |
| D-0236-2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.; 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. | 87,600 bottles | 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 |
| D-0237-2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.; Lot Numbers: 19234955, 19234956, Exp.: 11/2025; 19240971, Exp.: 2/2026; 19241864, Exp.: 4/2026. | 39,168 bottles | 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 |
| D-0238-2025 | 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.; Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026. | 120,000 bottles | 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01 |
| D-0239-2025 | 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.; 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. | 119,040 bottles | 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01 |
| D-0240-2025 | 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.; 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. | 133,824 bottles | 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01 |
| D-0241-2025 | 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.; Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026. | 233,040 bottles | 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01 |
| D-0242-2025 | 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.; Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026. | 53,952 bottles | 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01 |
| D-0243-2025 | 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.; Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026. | 58,416 bottles | 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01 |
| D-0244-2025 | 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.; Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026. | 58,368 bottles | 16714-755-01, 16714-756-01, 16714-757-01, 16714-758-01, 16714-759-01, 16714-760-01, 16714-761-01 |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the capsule bottle label to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Glenmark recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0236-2025 (January 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0236-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.