CLASS II Drug recall · Reported 17 Oct 2018 · FDA Enforcement Report
Glipizide XL (glipizide) extended-release tablets 5 mg recalled
Pfizer is recalling Glipizide XL (glipizide) extended-release tablets 5 mg, distributed nationwide in the US. The recall was initiated on 20 Sep 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0010-2019
- FDA event ID
- 81028
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2018
- FDA classified
- 9 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Diabetes Medication
Timeline
| 20 Sep 2018 | Recall initiated by company | |
| 9 Oct 2018 | Classified by FDA | +19 days |
| 17 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; rejected product was used to manufacture final bulk lot
Product as listed by the FDA
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations; rejected product was used to manufacture final bulk lot
Which lots are affected?
Lot: T71137 Exp. Feb. 2022
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Glipizide Xl (glipizide recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Glipizide XL (glipizide) extended release tablets, 5 mg recalled | Greenstone | Potency & Assay | Nationwide |