Food, drugs, devices › Amerisource Health Services

Drug recall: Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packa

FDA enforcement event 78118 · Class III · initiated 29 Aug 2017 · status Terminated · terminated 21 Aug 2019

DrugVoluntary: Firm initiated1 product recordColumbus, OH

Amerisource Health Services (Columbus, OH) initiated this drug recall on 29 Aug 2017; FDA lists 1 product record under event 78118, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 30% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 21 Aug 2019. 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 Stability Specifications"

Distribution

"Nationwide USA and Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0074-2018	Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01	93,600 tablets	Class III	Terminated	22 Nov 2017

Context

30%of 2017 drug events are Class III343 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
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
3 Feb 2017	GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx O	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 Stability Specifications"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide USA and Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Aug 2019. "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.