AbbVie Recalls
20 recalls on record · August 28, 2013 to June 3, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 3, 2026DrugsFDA
AbbVie Inc. recalls PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie co
Hazard: Failed Stability Specifications
October 2, 2024DrugsFDA
AbbVie Inc. recalls Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Dis
Hazard: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
October 2, 2024DrugsFDA
AbbVie Inc. recalls Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distribut
Hazard: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
November 15, 2023DrugsFDA
AbbVie Inc. recalls Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 6
Hazard: Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
February 7, 2018DrugsFDA
AbbVie Inc. recalls Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, US
Hazard: Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
November 1, 2017DrugsFDA
AbbVie Inc. recalls AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: A
Hazard: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
November 1, 2017DrugsFDA
AbbVie Inc. recalls AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump
Hazard: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
June 7, 2017Medical DevicesFDA
AbbVie Inc. recalls AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Hazard: PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
June 7, 2017Medical DevicesFDA
AbbVie Inc. recalls AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Hazard: PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
June 7, 2017Medical DevicesFDA
AbbVie Inc. recalls AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Hazard: FDA Class II
March 8, 2017DrugsFDA
AbbVie Inc. recalls Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Onl
Hazard: Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
December 28, 2016Medical DevicesFDA
AbbVie Inc. recalls AbbVie PEG Kit 20 FR
Hazard: AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.
April 27, 2016DrugsFDA
AbbVie Inc. recalls Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-
Hazard: Failed Content Uniformity Specifications
October 8, 2014DrugsFDA
AbbVie Inc recalls CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only. Marketed by: AbbVi
Hazard: Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
May 7, 2014DrugsFDA
AbbVie Inc recalls Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syring
Hazard: Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
May 7, 2014DrugsFDA
AbbVie Inc recalls Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syring
Hazard: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
May 7, 2014DrugsFDA
AbbVie Inc recalls LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber sy
Hazard: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
May 7, 2014DrugsFDA
AbbVie Inc recalls Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syring
Hazard: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
May 7, 2014DrugsFDA
AbbVie Inc recalls Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syring
Hazard: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
August 28, 2013DrugsFDA
AbbVie Inc. recalls Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for
Hazard: Labeling: Incorrect Package Insert; product packaged with outdated version of the insert