Mylan Pharmaceuticals Inc. recalls Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Mylan recalls 100-count Loxapine 50mg capsules (NDC 0378-7050-01) due to CGMP deviations. Affected lots expire 10/31/18 or 3/31/19. Consumers should check lot numbers on bottles.
Lower-risk recall
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 100-count Loxapine 50mg capsules that were made with CGMP deviations. This recall affects specific batch numbers that expired between October 2018 and March 2019. The issue means the product may not meet quality standards, but there are no reported injuries. Read more at govinfonow.com/recall/40597-mylan-loxapine-capsules-50mg-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40597-mylan-loxapine-capsules-50mg-recall-cgmp-deviations-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0825-2018
Cite this page
“Mylan Loxapine Capsules 50mg Recall: CGMP Deviations Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40597-mylan-loxapine-capsules-50mg-recall-cgmp-deviations-risk. Based on FDA recall #D-0825-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0825-2018%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in manufacturing quality control processes. This could mean the capsules do not meet the required safety and purity standards for medication. However, the recall does not indicate a specific safety risk like injury or illness.
Who’s affected
Prescription patients who received the recalled Loxapine capsules. People using these capsules for mental health conditions are most at risk if they have the affected batch numbers.
How to tell if you have this one
Check the bottle for the lot numbers: 3079386-3083767. The capsules expire by October 31, 2018 or March 31, 2019. The product is labeled as Loxapine 50mg, 100-count, NDC 0378-7050-01.
- Brand
Mylan- Category
Drug
All 2 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
Terminated- Distribution
Product was distributed throughout the United States, including Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0824-2018 | Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01; NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19 | 8,679 bottles |
| D-0825-2018 | Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01; NDC 0378-7050-01 Lot Numbers: 3079386, Exp. 10/31/18 3079387, Exp. 10/31/18 3079388, Exp. 10/31/18 3083762, Exp. 3/31/19 3083763, Exp. 3/31/19 3083764, Exp. 3/31/19 3083765, Exp. 3/31/19 3083766, Exp. 3/31/19 3083767, Exp. 3/31/19 | 11,650 bottles |
What to do — step by step
Check Lot Numbers
Look for lot numbers 3079386 through 3083767 on the bottle.
Questions people ask
Do I need to stop using these capsules?
No, the recall does not require stopping use. The issue is a manufacturing quality concern, not a safety hazard.
What should I do if I have the recalled capsules?
Check the lot numbers on the bottle. If it matches the recalled numbers, contact Mylan for instructions.
Are there any injuries reported from this recall?
The recall record does not mention any injuries or health issues.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0825-2018 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0825-2018 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0825-2018 (April 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0825-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.