Food, drugs, devices › Amerisource Health Services

Drug recall: GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx O

FDA enforcement event 76636 · Class II · initiated 3 Feb 2017 · status Terminated · terminated 1 Mar 2018

DrugVoluntary: Firm initiated1 product recordColumbus, OH

FDA enforcement event 76636 is a drug recall by Amerisource Health Services of Columbus, OH, initiated 3 Feb 2017 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 1 Mar 2018. Initiation: voluntary: firm initiated. Amerisource Health Services has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Amerisource Health Services, Columbus, OH.

Reason for recall

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

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0520-2017	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	19,393 cartons (581,790 extended release tablets)	Class II	Terminated	22 Mar 2017

Context

57%of 2017 drug events are Class II343 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for Amerisource Health Services

Initiated	Product (first record)	Type	Class	Records
24 Oct 2017	Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohi	Drug	Class II	1
29 Aug 2017	Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packa	Drug	Class III	1
8 Feb 2017	CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, C	Drug	Class II	1
27 Oct 2016	Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count	Drug	Class III	1
13 Oct 2016	AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only	Drug	Class III	1
30 Sep 2016	Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containin	Drug	Class III	1
24 Aug 2016	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tabl	Drug	Class II	10
4 Aug 2016	buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila He	Drug	Class III	1
31 Mar 2016	Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and D	Drug	Class III	2
26 Jan 2016	Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Col	Drug	Class III	1

All 13 events for Amerisource Health Services

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 1 Mar 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.