Medications & Supplements/Prescription Drugs

Chiesi USA, Inc.: ZYFLO CR and Zileuton Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: June 7, 2019

Summary

Chiesi USA, Inc. has recalled approximately 4,716 bottles of ZYFLO CR (zileuton) and generic Zileuton extended-release tablets (600 mg, 120-count). The recall was initiated because the medication failed dissolution testing, meaning the tablets may not release the active ingredient into the body at the correct rate. These prescription drugs are used for the chronic treatment of asthma, and a failure to release the medication properly could lead to ineffective treatment or unexpected health outcomes.

Risk

If the tablets do not dissolve as specified, the patient may receive too much or too little of the medication at one time. This can result in the medication being ineffective at managing asthma symptoms or potentially causing adverse effects due to inconsistent dosing.

What You Should Do

Check your prescription bottles for ZYFLO CR (zileuton) 600 mg (NDC 10122-902-12) with lot number 3171855 and an expiration date of 12/19.
Check for generic Zileuton Extended-Release 600 mg (NDC 66993-485-32) with lot number 3171856 and an expiration date of 12/19.
If you identify an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your asthma treatment and obtain a replacement.
Return any unused or affected medication to the pharmacy where it was purchased for a refund.
Contact Chiesi USA, Inc. at their Cary, North Carolina office or through your pharmacist for further instructions regarding this recall.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return unused product to the pharmacy for a refund.

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

Affected Products

Product: ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles

Model:

NDC 10122-902-12

Lot Numbers:

3171855 (Exp. 12/19)

Date Ranges: Expiration Date: 12/19

Product: Zileuton Extended-Release Tablets, 600 mg, 120-count bottles

Model:

NDC 66993-485-32

Lot Numbers:

3171856 (Exp. 12/19)

Date Ranges: Expiration Date: 12/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82993

Status: Resolved

Manufacturer: Chiesi USA, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (2118 bottles; 2598 bottles)

Distributed To: Nationwide

Agency Last Updated: June 13, 2019

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 prescription bottles for ZYFLO CR (zileuton) 600 mg (NDC 10122-902-12) with lot number 3171855 and an expiration date of 12/19.

Check for generic Zileuton Extended-Release 600 mg (NDC 66993-485-32) with lot number 3171856 and an expiration date of 12/19.

If you identify an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your asthma treatment and obtain a replacement.

Return any unused or affected medication to the pharmacy where it was purchased for a refund.

Contact Chiesi USA, Inc. at their Cary, North Carolina office or through your pharmacist for further instructions regarding this recall.

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

Affected Products

Product: ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles

Model:

NDC 10122-902-12

Lot Numbers:

3171855 (Exp. 12/19)

Date Ranges: Expiration Date: 12/19

Product: Zileuton Extended-Release Tablets, 600 mg, 120-count bottles

Model:

NDC 66993-485-32

Lot Numbers:

3171856 (Exp. 12/19)

Date Ranges: Expiration Date: 12/19