Medications & Supplements/Prescription Drugs

Mylan Institutional, Inc. (d.b.a. UDL Laboratories): Loxapine Capsules Recalled Due to Potential Cross-Contamination Risk

Agency Publication Date: May 22, 2018

Summary

Mylan Institutional, Inc. is recalling 2,217 units of Loxapine (loxapine succinate) capsules in 25 mg and 50 mg strengths. This recall was initiated after an FDA inspection found manufacturing violations that could allow for cross-contamination between different drug products. Consumers should contact their healthcare provider or pharmacist regarding this recall and for guidance on their medication regimen.

Risk

Manufacturing site violations created a risk that these capsules could be contaminated with other pharmaceutical substances, which could lead to unexpected side effects or dangerous drug interactions.

What You Should Do

Check your medication packaging for Loxapine Capsules, USP 25 mg (NDC 51079-902-20) with lot number 3090454 and expiration date 03/2019.
Check your medication packaging for Loxapine Capsules, USP 50 mg (NDC 51079-903-20) with lot number 3092310 and expiration date 03/2019.
Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking your current supply or obtain a replacement.
Return any unused blister cards from the affected lots to your pharmacy for a refund.
Contact Mylan Pharmaceuticals Inc. for further instructions or questions regarding this recall.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

Full Refund

Healthcare consultation and pharmaceutical refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Loxapine Capsules, USP 25 mg (100 Unit Dose Capsules)

Model:

NDC 51079-902-20

D-0822-2018

Lot Numbers:

3090454 (Exp. 03/2019)

Date Ranges: 03/2019

Product: Loxapine Capsules, USP 50 mg (100 Unit Dose Capsules)

Model:

NDC 51079-903-20

D-0823-2018

Lot Numbers:

3092310 (Exp. 03/2019)

Date Ranges: 03/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79977

Status: Resolved

Manufacturer: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold By: hospitals; pharmacies; institutional providers

Manufactured In: United States

Units Affected: 2 products (1,065 blister cards of 100 capsules each; 1,152 blister cards of 100 capsules each)

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.

Find an Attorney

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 · 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.

Summary

What You Should Do

Check your medication packaging for Loxapine Capsules, USP 25 mg (NDC 51079-902-20) with lot number 3090454 and expiration date 03/2019.

Check your medication packaging for Loxapine Capsules, USP 50 mg (NDC 51079-903-20) with lot number 3092310 and expiration date 03/2019.

Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking your current supply or obtain a replacement.

Return any unused blister cards from the affected lots to your pharmacy for a refund.

Contact Mylan Pharmaceuticals Inc. for further instructions or questions regarding this recall.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Affected Products

Product: Loxapine Capsules, USP 25 mg (100 Unit Dose Capsules)

Model:

NDC 51079-902-20

D-0822-2018

Lot Numbers:

3090454 (Exp. 03/2019)

Date Ranges: 03/2019

Product: Loxapine Capsules, USP 50 mg (100 Unit Dose Capsules)

Model:

NDC 51079-903-20

D-0823-2018

Lot Numbers:

3092310 (Exp. 03/2019)

Date Ranges: 03/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79977

Status: Resolved

Manufacturer: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold By: hospitals; pharmacies; institutional providers

Manufactured In: United States

Units Affected: 2 products (1,065 blister cards of 100 capsules each; 1,152 blister cards of 100 capsules each)

Distributed To: Nationwide