Medications & Supplements/Prescription Drugs

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

Agency Publication Date: October 20, 2021

Summary

American Health Packaging is recalling 2,266 cartons of GlipiZIDE Extended-Release Tablets (2.5 mg), a medication used to treat type 2 diabetes. The recall was initiated because the tablets failed dissolution tests, meaning the medicine may be released into the body faster or slower than intended. The affected product was distributed nationwide in cartons containing 30 individually blistered doses.

Risk

When extended-release medications fail dissolution specifications, they may release the active ingredient too quickly. This can lead to the drug not working as intended to manage blood sugar levels or potentially causing side effects related to a rapid release of the medication.

What You Should Do

Check your medication packaging for GlipiZIDE Extended-Release Tablets, 2.5 mg, in 30-count cartons (3 blister cards of 10 doses each).
Look for Lot number 1941 with an Expiration Date of 03/31/2022 on the carton or the individual blister cards.
Verify the National Drug Code (NDC) on your packaging: the carton NDC is 68084-295-21 and the individual dose NDC is 68084-295-11.
If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on how to safely switch to a replacement and to discuss any concerns regarding your blood sugar management.
Return any unused product to your pharmacy for a refund and contact American Health Packaging at 2550 John Glenn Ave Ste A, Columbus, Ohio for further instructions.
For additional questions, 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 medical 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

Model:

Carton NDC: 68084-295-21

Individual Dose NDC: 68084-295-11

Recall #: D-0020-2022

Lot Numbers:

194141 (Exp. 03/31/2022)

Date Ranges: 03/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88734

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2,266 cartons

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 GlipiZIDE Extended-Release Tablets, 2.5 mg, in 30-count cartons (3 blister cards of 10 doses each).

Look for Lot number 1941 with an Expiration Date of 03/31/2022 on the carton or the individual blister cards.

Verify the National Drug Code (NDC) on your packaging: the carton NDC is 68084-295-21 and the individual dose NDC is 68084-295-11.

If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on how to safely switch to a replacement and to discuss any concerns regarding your blood sugar management.

Return any unused product to your pharmacy for a refund and contact American Health Packaging at 2550 John Glenn Ave Ste A, Columbus, Ohio for further instructions.

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