CLASS II Drug recall · Reported 1 Mar 2017 · FDA Enforcement Report
Glipizide 2.5 mg ER Tablets recalled by RemedyRepack
RemedyRepack is recalling Glipizide 2.5 mg ER Tablets, distributed in Florida. The recall was initiated on 7 Feb 2017 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-0482-2017
- FDA event ID
- 76457
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2017
- FDA classified
- 18 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 7 Feb 2017 | Recall initiated by company | |
| 18 Feb 2017 | Classified by FDA | +11 days |
| 1 Mar 2017 | Published in enforcement report | +11 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 Specifications
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 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
Where it was distributed
Product was distributed to a sold customer in FL.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot # B0129373-021916; Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC
Where was it sold?
Product was distributed to a sold customer in FL.
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.
More recalls from RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
Other Glipizide recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | glipiZIDE, Extended-Release Tablets, 2.5 mg ( blister cards) recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | GlipiZIDE Extended-Release Tablets, 2.5 mg recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | GlipiZIDE Extended-release Tablets, 2.5 mg (3 recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | GlipiZIDE Extended-release tablets, 2.5 mg carton recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | glipiZIDE Extended-Release Tablets, 5 mg recalled | Mylan Pharmaceuticals | Other | Nationwide |