Mylan Recalls Loxapine Capsules 50 mg Due to CGMP Deviations
Mylan Pharmaceuticals recalls 11,650 bottles of Loxapine Capsules USP 50 mg due to Current Good Manufacturing Practice deviations. Check your lot numbers.
Use caution until it’s fixed
CGMP Deviations
Contact the company
What happened, in plain English
Mylan Pharmaceuticals Inc. is recalling 11,650 bottles of Loxapine Capsules, USP 50 mg because the product was manufactured with deviations from Current Good Manufacturing Practices (CGMP). The recall affects specific lots distributed throughout the United States and Puerto Rico. The record does not specify a remedy or list any reported injuries. Read more at govinfonow.com/recall/40597-mylan-recalls-loxapine-capsules-50-mg-due-to-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/40597-mylan-recalls-loxapine-capsules-50-mg-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0825-2018
Cite this page
“Mylan Recalls Loxapine Capsules 50 mg Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40597-mylan-recalls-loxapine-capsules-50-mg-due-to-cgmp-deviations. 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
The recall is due to CGMP deviations, which means the manufacturing process did not meet federal quality standards. While the record does not describe specific injuries or defects, such deviations can potentially affect the safety, strength, quality, or purity of the medication.
Who’s affected
Individuals who have been prescribed Loxapine Capsules, USP 50 mg by a healthcare provider. Consumers in the United States and Puerto Rico who purchased these specific bottles are at risk.
How to tell if you have this one
Look for 100-count bottles labeled 'Loxapine Capsules, USP 50 mg, Rx Only' with NDC 0378-7050-01. Check the bottle for one of these lot numbers and expiration dates: Lot 3079386 (Exp. 10/31/18), Lot 3079387 (Exp. 10/31/18), Lot 3079388 (Exp. 10/31/18), Lot 3083762 (Exp. 3/31/19), Lot 3083763 (Exp. 3/31/19), Lot 3083764 (Exp. 3/31/19), Lot 3083765 (Exp. 3/31/19), Lot 3083766 (Exp. 3/31/19), or Lot 3083767 (Exp. 3/31/19).
- Brand
Mylan Pharmaceuticals- 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 Your Medication
Verify if your bottle matches the recalled NDC and lot numbers listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the appropriate next steps for your prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States, including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Mylan Pharmaceuticals 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-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 qwen3.6:35b-a3b on October 11, 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.