The Recall Desk
ModerateFDA (Drugs)·D-0010-2019·Announced 2018-10-17

Pfizer Recalls Glipizide XL Tablets Due to Manufacturing Deviations

Pfizer is recalling 7,777 bottles of Glipizide XL 5 mg tablets because rejected product was used in manufacturing, violating CGMP standards.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (use of rejected product) without reported illnesses or injuries, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Pfizer Inc. is recalling 7,777 bottles of Glipizide XL (glipizide) extended-release tablets, 5 mg, 500-tablet bottles. The product is distributed by Greenstone LLC and is available nationwide. The specific lot affected is T71137, with an expiration date of February 2022.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, rejected product was used to manufacture the final bulk lot, which constitutes a violation of manufacturing standards.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
Manufacturer
Pfizer Inc.
Affected units
7,777

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: T71137 Exp. Feb. 2022

Distribution

Distributed nationwide across the United States.