Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc.
Mylan recalls 50mg Loxap: FDA found manufacturing issues that could cause cross contamination. Patients should contact pharmacy for replacement.
Lower-risk recall
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 50mg Loxapine capsules due to FDA findings of manufacturing problems that might lead to cross contamination. This affects prescription-only medication sold in specific packaging. Read more at govinfonow.com/recall/40578-mylan-loxapine-capsules-50mg-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40578-mylan-loxapine-capsules-50mg-recall-cross-contamination-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0823-2018
Cite this page
“Mylan Loxapine Capsules 50mg Recall: Cross Contamination Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40578-mylan-loxapine-capsules-50mg-recall-cross-contamination-risk. Based on FDA recall #D-0823-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0823-2018%22&limit=1).
Why it’s dangerous
The FDA found multiple manufacturing violations at the facility that could lead to cross contamination. This means the medication might contain harmful substances from other products during production.
Who’s affected
Prescription patients using the recalled Loxapine capsules. Those with the specific NDC number 51079-903-20 and lot number 3092310 are most at risk.
How to tell if you have this one
Check for the NDC number 51079-903-20 and lot number 3092310 on the packaging. The capsules are prescription-only and sold in 100-unit doses.
- 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
Nationwide in the U.S.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0822-2018 | Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20; Lot #: 3090454, Exp. 03/2019 | 1,065 blister cards of 100 capsules each |
| D-0823-2018 | Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.; Lot #: 3092310, Exp. 03/2019 | 1,152 blister cards of 100 capsules each |
What to do — step by step
Contact Pharmacy
Talk to your pharmacy about getting a replacement for the recalled Loxapine capsules.
Questions people ask
Is this product safe to use?
The FDA found manufacturing issues that could cause cross contamination, so it's not safe to use the recalled lot.
How do I know if I have the recalled product?
Check the packaging for NDC number 51079-903-20 and lot number 3092310.
What should I do if I have the recalled product?
Contact your pharmacy for a replacement; do not use the recalled capsules.
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-0823-2018 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0823-2018 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-0823-2018 (May 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0823-2018 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.