CLASS II Drug recall · Reported 8 May 2019 · FDA Enforcement Report

GlipiZIDE Extended-release Tablets, 5 mg (3 x recalled

American Health Packaging is recalling GlipiZIDE Extended-release Tablets, 5 mg (3 x, distributed nationwide in the US. The recall was initiated on 8 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 181288, EXP 5/31/2020

Quantity recalled2,203 cartons (cartons of 30 individual unit doses)

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-1276-2019
FDA event ID: 82593
Recalling firm: American Health Packaging, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 8 Apr 2019
FDA classified: 10 May 2019
Reported: 8 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Diabetes Medication

Timeline

8 Apr 2019	Recall initiated by company
8 May 2019	Published in enforcement report	+30 days
10 May 2019	Classified by FDA	+2 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: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.

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 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Is GlipiZIDE Extended-release Tablets, 5 mg (3 x recalled?

Yes. American Health Packaging recalled GlipiZIDE Extended-release Tablets, 5 mg (3 x on 8 Apr 2019. The recall is Class II and its status is Terminated. Recall number D-1276-2019.

Why was it recalled?

Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.

Which lots are affected?

Lot # 181288, EXP 5/31/2020

Where was it sold?

Nationwide in 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 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.

More recalls from American Health Packaging

All 59

Reported	Class	Recall	Company	Reason	Where
25 May 2022Drug	CLASS III	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled	American Health Packaging	Potency & Assay	Nationwide
4 May 2022Drug	CLASS III	Cyanocobalamin Injection, USP, 1000 mcg per mL recalled	American Health Packaging	Potency & Assay	AL
16 Mar 2022Drug	CLASS II	Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride	American Health Packaging	Potency & Assay	Nationwide
2 Feb 2022Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate	American Health Packaging	Potency & Assay	Nationwide
27 Oct 2021Drug	CLASS II	GlipiZIDE Extended-Release Tablets, 5 mg recalled	American Health Packaging	Potency & Assay	Nationwide

Other Glipizide recalls

All 7

Reported	Class	Recall	Company	Reason	Where
27 Oct 2021Drug	CLASS II	GlipiZIDE Extended-Release Tablets, 5 mg recalled	American Health Packaging	Potency & Assay	Nationwide
16 Aug 2017Drug	CLASS III	Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg recalled	Teva Pharmaceuticals U	Potency & Assay	6 states
22 Mar 2017Drug	CLASS II	GlipiZIDE Extended-release tablets, 5 mg carton recalled	Amerisource Health Services	Potency & Assay	Nationwide
8 Mar 2017Drug	CLASS II	glipiZIDE Extended-Release Tablets, 5 mg recalled	Mylan Pharmaceuticals	Other	Nationwide
22 Feb 2017Drug	CLASS II	Glipizide extended-release tablets, 5mg recalled by Actavis	Actavis	Potency & Assay	Nationwide