Recall Register

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AbbVie Inc.

FDA recalling firm · 12 enforcement events · 20 product records · 2013–2026 · IL

AbbVie Inc. has 12 FDA enforcement events on this register (20 product records) between 2013 and 2026: 10 drug and 2 device; the busiest year was 2017 with 3.

0% of its events are Class I; the most common class is Class II (6). 3 events are listed as ongoing; the recalling firm's address is in IL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
18 May 2026PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.DrugClass III1Ongoing
16 Sep 2024Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,DrugClass II2Ongoing
17 Oct 2023Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11DrugClass III1Ongoing
22 Jan 2018Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51DrugClass III1Terminated
8 Sep 2017AndroGel (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: 0051-8462-33DrugClass III2Terminated
27 Apr 2017AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.DeviceClass II3Terminated
13 Jan 2017Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07DrugClass II1Terminated
22 Nov 2016AbbVie PEG Kit 20 FRDeviceClass II1Terminated
24 Mar 2016Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.DrugClass III1Terminated
15 Sep 2014CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064, Product of Germany. NDC 0032-1224-07.DrugClass II1Terminated
10 Mar 2014Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3…DrugClass II5Terminated
1 Aug 2013Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USADrugClass III1Terminated

By type and class

Drug10
Device2
Class II6
Class III6

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for AbbVie Inc. by year initiated.

Questions and answers

How many FDA recalls has AbbVie Inc. had?

12 enforcement events (20 product records) on this register, 2013–2026: 10 drug, 2 device.

Are any AbbVie Inc. recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are AbbVie Inc. recalls?

6 Class II, 6 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.