Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Loxapine Capsules Recalled for Manufacturing Deviations

Agency Publication Date: May 22, 2018

Summary

Mylan Pharmaceuticals Inc. has recalled approximately 20,329 bottles of Loxapine capsules, a prescription medication used to treat schizophrenia. The recall includes Loxapine Capsules USP in 25 mg and 50 mg strengths (100-count bottles) due to deviations from Current Good Manufacturing Practice (CGMP) standards. These deviations mean the medication may not meet quality requirements for purity, strength, or safety. Consumers currently taking this medication should contact their healthcare provider or pharmacist for guidance before stopping use.

Risk

Manufacturing deviations can lead to inconsistent drug quality, which may impact the effectiveness or safety of the medication. No specific injuries or adverse events were reported in the recall data.

What You Should Do

Check your medication bottle to see if you have Loxapine Capsules, USP 25 mg (NDC 0378-7025-01) with any of the following Lot Numbers: 3083756, 3083757, 3083758, 3083759, 3083760, or 3083761 (all expiring 3/31/19).
Check if you have Loxapine Capsules, USP 50 mg (NDC 0378-7050-01) with any of the following Lot Numbers: 3079386, 3079387, 3079388 (Exp. 10/31/18) or 3083762, 3083763, 3083764, 3083765, 3083766, 3083767 (Exp. 3/31/19).
If you identify your medication as part of the recall, contact your healthcare provider or pharmacist immediately to discuss a replacement or alternative treatment options.
Return any unused product to the pharmacy where it was purchased for a refund and contact Mylan Pharmaceuticals Inc. at 1-888-723-3332 for further instructions.
For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return for 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-count bottles)

Model:

D-0824-2018

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)

Date Ranges: Exp. 3/31/19

Product: Loxapine Capsules, USP 50 mg (100-count bottles)

Model:

D-0825-2018

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)

Date Ranges: Exp. 10/31/18, Exp. 3/31/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79955

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (8,679 bottles; 11,650 bottles)

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 bottle to see if you have Loxapine Capsules, USP 25 mg (NDC 0378-7025-01) with any of the following Lot Numbers: 3083756, 3083757, 3083758, 3083759, 3083760, or 3083761 (all expiring 3/31/19).

Check if you have Loxapine Capsules, USP 50 mg (NDC 0378-7050-01) with any of the following Lot Numbers: 3079386, 3079387, 3079388 (Exp. 10/31/18) or 3083762, 3083763, 3083764, 3083765, 3083766, 3083767 (Exp. 3/31/19).

If you identify your medication as part of the recall, contact your healthcare provider or pharmacist immediately to discuss a replacement or alternative treatment options.

Return any unused product to the pharmacy where it was purchased for a refund and contact Mylan Pharmaceuticals Inc. at 1-888-723-3332 for further instructions.

For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Loxapine Capsules, USP 25 mg (100-count bottles)

Model:

D-0824-2018

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)

Date Ranges: Exp. 3/31/19

Product: Loxapine Capsules, USP 50 mg (100-count bottles)

Model:

D-0825-2018

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)

Date Ranges: Exp. 10/31/18, Exp. 3/31/19