Medications & Supplements/Prescription Drugs

Pfizer Inc.: Glipizide XL Extended-Release Tablets Recalled for Manufacturing Deviations

Agency Publication Date: October 9, 2018

Summary

Pfizer Inc. is recalling approximately 7,777 bottles of Glipizide XL (glipizide) extended-release tablets, 5 mg. The recall was initiated because a portion of product that had been previously rejected was mistakenly used to manufacture a final bulk lot of the medication. This manufacturing error (CGMP deviation) means the tablets may not meet established quality and safety standards. These prescription tablets were distributed nationwide in 500-count bottles under the Greenstone LLC label.

Risk

The use of rejected material in a final medication lot can result in inconsistent drug potency or the presence of impurities, which may lead to ineffective blood sugar control or unexpected side effects for patients with diabetes.

What You Should Do

Check your medication bottle to see if it is Glipizide XL (glipizide) extended-release tablets, 5 mg, in a 500-count bottle distributed by Greenstone LLC.
Locate the lot number and expiration date on the side of the bottle. This recall specifically affects lot number T71137 with an expiration date of February 2022 (Exp. Feb. 2022).
Verify the National Drug Code (NDC) printed on the bottle matches NDC 59762-0541-2.
If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on whether you should continue use or obtain a replacement.
Return any unused portions of the affected medication to your pharmacy to receive a refund.
Contact Pfizer Inc. at 1-800-438-1985 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Glipizide XL (glipizide) extended-release tablets 5 mg (500-tablet bottle)

Model:

NDC 59762-0541-2

Recall #: D-0010-2019

Lot Numbers:

T71137 (Exp. Feb. 2022)

Date Ranges: Expiration February 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81028

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Greenstone LLC; Pharmacies

Manufactured In: United States

Units Affected: 7777 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 it is Glipizide XL (glipizide) extended-release tablets, 5 mg, in a 500-count bottle distributed by Greenstone LLC.

Locate the lot number and expiration date on the side of the bottle. This recall specifically affects lot number T71137 with an expiration date of February 2022 (Exp. Feb. 2022).

Verify the National Drug Code (NDC) printed on the bottle matches NDC 59762-0541-2.

If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on whether you should continue use or obtain a replacement.

Return any unused portions of the affected medication to your pharmacy to receive a refund.

Contact Pfizer Inc. at 1-800-438-1985 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.