Medications & Supplements/Prescription Drugs

American Health Packaging: GlipiZIDE Extended-release Tablets Recalled for Failed Dissolution

Agency Publication Date: April 26, 2019

Summary

American Health Packaging has recalled 2,203 cartons of GlipiZIDE Extended-release Tablets (2.5 mg), a prescription medication used to treat type 2 diabetes. The recall was initiated because testing showed the medication released its active ingredients too quickly (dissolution failure) at the time of packaging. This defect means the drug may not perform as intended in the body, potentially affecting blood sugar control. These tablets were distributed nationwide in the USA in cartons containing 30 individual unit doses.

Risk

Because the tablets released the medication slightly faster than specified at 'time zero,' there is a risk that the extended-release mechanism could fail, leading to improper dosing or ineffective treatment of blood sugar levels.

What You Should Do

Immediately check your medication packaging for GlipiZIDE Extended-release Tablets, 2.5 mg, with NDC: 68084-295-21.
Verify if your medication is part of the affected lot by looking for Lot # 181288 with an expiration date of 5/31/2020.
Contact your healthcare provider or pharmacist immediately for guidance if you find you are using the affected medication. Do not stop taking your prescribed diabetes medication until you have spoken with a medical professional to arrange a safe alternative.
Return any unused product from Lot 181288 to your pharmacy for a refund and contact American Health Packaging for further instructions regarding the return process.
For additional information or to report a concern, 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

Pharmacy refund and healthcare consultation.

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

Affected Products

Product: GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10)

Model:

NDC: 68084-295-21

Recall #: D-1276-2019

Lot Numbers:

181288 (EXP 5/31/2020)

Date Ranges: 5/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82593

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2,203 cartons (cartons of 30 individual unit doses)

Distributed To: Nationwide

Agency Last Updated: May 10, 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

Immediately check your medication packaging for GlipiZIDE Extended-release Tablets, 2.5 mg, with NDC: 68084-295-21.

Verify if your medication is part of the affected lot by looking for Lot # 181288 with an expiration date of 5/31/2020.

Contact your healthcare provider or pharmacist immediately for guidance if you find you are using the affected medication. Do not stop taking your prescribed diabetes medication until you have spoken with a medical professional to arrange a safe alternative.

Return any unused product from Lot 181288 to your pharmacy for a refund and contact American Health Packaging for further instructions regarding the return process.

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