CLASS II Drug recall · Reported 22 Mar 2017 · FDA Enforcement Report

GlipiZIDE Extended-release tablets, 2.5 mg carton recalled

Amerisource Health Services is recalling GlipiZIDE Extended-release tablets, 2.5 mg carton (, distributed nationwide in the US. The recall was initiated on 3 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17

Quantity recalled19,393 cartons (581,790 extended release tablets)

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-0520-2017
FDA event ID: 76636
Recalling firm: Amerisource Health Services, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 3 Feb 2017
FDA classified: 14 Mar 2017
Reported: 22 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Diabetes Medication

Timeline

3 Feb 2017	Recall initiated by company
14 Mar 2017	Classified by FDA	+39 days
22 Mar 2017	Published in enforcement report	+8 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: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

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-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

Which lots are affected?

Lot #160133, 160549 Exp. 08/17 Lot #162006; Exp. 09/17 Lot #163348A, 163348B; Exp. 10/17

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.

More recalls from Amerisource Health Services

All 69

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
5 Nov 2025Drug	CLASS II	Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride	Amerisource Health Services	Nitrosamine Impurity	Nationwide

Other Glipizide recalls

All 9

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Drug	CLASS II	glipiZIDE, Extended-Release Tablets, 2.5 mg ( blister cards) recalled	Amerisource Health Services	Potency & Assay	Nationwide
27 Oct 2021Drug	CLASS II	GlipiZIDE Extended-Release Tablets, 2.5 mg recalled	American Health Packaging	Potency & Assay	Nationwide
8 May 2019Drug	CLASS II	GlipiZIDE Extended-release Tablets, 2.5 mg (3 recalled	American Health Packaging	Potency & Assay	Nationwide
8 Mar 2017Drug	CLASS II	glipiZIDE Extended-Release Tablets, 5 mg recalled	Mylan Pharmaceuticals	Other	Nationwide
1 Mar 2017Drug	CLASS II	Glipizide 2.5 mg ER Tablets recalled by RemedyRepack	RemedyRepack	Potency & Assay	FL