Drug recall: AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump

FDA enforcement event 78143 · Class III · initiated 8 Sep 2017 · status Terminated · terminated 23 Apr 2018

DrugVoluntary: Firm initiated2 product recordsNorth Chicago, IL

AbbVie Inc. (North Chicago, IL) initiated this drug recall on 8 Sep 2017; FDA lists 2 product records under event 78143, 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 23 Apr 2018. Initiation: voluntary: firm initiated. AbbVie Inc. has 12 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

AbbVie Inc., North Chicago, IL.

Reason for recall

"Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions."

Distribution

"AZ"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0033-2018	AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33	520 pumps	Class III	Terminated	1 Nov 2017
D-0034-2018	AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30	48 cartons (30 foil packets per carton)	Class III	Terminated	1 Nov 2017

Context

30%of 2017 drug events are Class III343 events that year

2product records in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for AbbVie Inc.

Initiated	Product (first record)	Type	Class	Records
18 May 2026	PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie co	Drug	Class III	1
16 Sep 2024	Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distribut	Drug	Class II	2
17 Oct 2023	Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 6	Drug	Class III	1
22 Jan 2018	Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA	Drug	Class III	1
27 Apr 2017	AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.	Device	Class II	3
13 Jan 2017	Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Onl	Drug	Class II	1
22 Nov 2016	AbbVie PEG Kit 20 FR	Device	Class II	1
24 Mar 2016	Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-	Drug	Class III	1
15 Sep 2014	CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVi	Drug	Class II	1
10 Mar 2014	Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syring	Drug	Class II	5

All 12 events for AbbVie Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions."

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: "AZ"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 23 Apr 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.