CLASS II Drug recall · Reported 27 Oct 2021 · FDA Enforcement Report
GlipiZIDE Extended-Release Tablets, 2.5 mg recalled
American Health Packaging is recalling GlipiZIDE Extended-Release Tablets, 2.5 mg (3 blister cards each with 10 individually, distributed nationwide in the US. The recall was initiated on 17 Sep 2021 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-0020-2022
- FDA event ID
- 88734
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2021
- FDA classified
- 20 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 17 Sep 2021 | Recall initiated by company | |
| 20 Oct 2021 | Classified by FDA | +33 days |
| 27 Oct 2021 | Published in enforcement report | +7 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: results were above specification.
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 Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: results were above specification.
Which lots are affected?
Lot #: 194141, Exp. Date 03/31/2022
Where was it sold?
Nationwide within the USA
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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| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | 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 (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 |
| Drug | CLASS II | Glipizide 2.5 mg ER Tablets recalled by RemedyRepack | RemedyRepack | Potency & Assay | FL |