Pfizer Recalls Glucotrol XL Tablets for Dissolution Specification Failure
Pfizer is recalling specific bottles of Glucotrol XL tablets because they failed to meet dissolution specifications at the 8-hour stability timepoint.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or specification issues without reported harm.
Plain-English summary
Pfizer Inc. is recalling 14,357 bottles of Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles. The product is distributed by Roerig, Division of Pfizer Inc, and is available by prescription only. The recall covers Lot V120131, identified by NDC 0049-1550-66.
The recall was initiated because the affected product failed to meet dissolution specifications at the 8-hour stability timepoint. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the United States, including Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.
The recalled product
- Product
- Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 14,357
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 V120131
Distribution
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