CLASS II Drug recall · Reported 8 Mar 2017 · FDA Enforcement Report
glipiZIDE Extended-Release Tablets, 5 mg recalled
Mylan Pharmaceuticals is recalling glipiZIDE Extended-Release Tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 19 Jan 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-0491-2017
- FDA event ID
- 76291
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jan 2017
- FDA classified
- 24 Feb 2017
- Reported
- 8 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 19 Jan 2017 | Recall initiated by company | |
| 24 Feb 2017 | Classified by FDA | +36 days |
| 8 Mar 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Product as listed by the FDA
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Which lots are affected?
Batch # 3074621, June 2018
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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|---|---|---|---|---|---|
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| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
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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 2.5 mg ER Tablets recalled by RemedyRepack | RemedyRepack | Potency & Assay | FL |