CLASS III Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Glipizide XL (glipizide) extended release tablets, 5 mg recalled
Greenstone is recalling Glipizide XL (glipizide) extended release tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 4 Nov 2013 and the FDA has classified it as Class III.
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-1059-2014
- FDA event ID
- 66814
- Recalling firm
- Greenstone, Peapack, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Nov 2013
- FDA classified
- 3 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 4 Nov 2013 | Recall initiated by company | |
| 3 Feb 2014 | Classified by FDA | +91 days |
| 12 Feb 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
Where it was distributed
US Nationwide (including PR)
Questions about this recall
Is Glipizide XL (glipizide) extended release tablets, 5 mg recalled?
Yes. Greenstone recalled Glipizide XL (glipizide) extended release tablets, 5 mg on 4 Nov 2013. The recall is Class III and its status is Terminated. Recall number D-1059-2014.
Why was it recalled?
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Which lots are affected?
lot V112000, EXP Jun 2016
Where was it sold?
US Nationwide (including PR)
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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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