Glipizide XL (Greenstone) – dissolution failure (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
Brand
Greenstone Llc
Lot Codes / Batch Numbers
lot V112000, EXP Jun 2016
Products Sold
lot V112000, EXP Jun 2016
Greenstone Llc is recalling Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by due to Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026