AbbVie Recalls

19 recalls on record in the United States

drugs: 16 medical: 3
medical Class II
2017-06-07

AbbVie Inc. recalls AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx

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.

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medical Class II
2017-06-07

AbbVie Inc. recalls AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx

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medical Class II
2017-06-07

AbbVie Inc. recalls AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx

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.

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drugs Class II
2024-10-02

AbbVie Inc. recalls Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lu

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

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drugs Class II
2024-10-02

AbbVie Inc. recalls Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolat

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

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drugs Class III
2023-11-15

AbbVie Inc. recalls Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg

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.

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drugs Class III
2018-02-07

AbbVie Inc. recalls Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only

Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

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drugs Class III
2017-11-01

AbbVie Inc. recalls AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum f

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

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drugs Class III
2017-11-01

AbbVie Inc. recalls AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump,

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

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drugs Class II
2017-03-08

AbbVie Inc. recalls Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/2

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

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drugs Class III
2016-04-27

AbbVie Inc. recalls Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx

Failed Content Uniformity Specifications

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drugs Class II
2014-10-08

AbbVie Inc recalls CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000

Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.

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drugs Class II
2014-05-07

AbbVie Inc recalls Lupron Depot (Leuprolide Acetate for Depot Suspension) Singl

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

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drugs Class II
2014-05-07

AbbVie Inc recalls Lupron Depot (Leuprolide Acetate for Depot Suspension) Singl

Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.

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drugs Class II
2014-05-07

AbbVie Inc recalls Lupron Depot (leuprolide acetate for depot suspension) Singl

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

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drugs Class II
2014-05-07

AbbVie Inc recalls LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) S

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

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drugs Class II
2014-05-07

AbbVie Inc recalls Lupron Depot (Leuprolide Acetate for Depot Suspension) Singl

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.

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drugs Class III
2013-08-28

AbbVie Inc. recalls Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only,

Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

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drugs Class III
2026-06-03

AbbVie Inc. recalls PRED MILD, prednisolone acetate ophthalmic suspension, USP,

Failed Stability Specifications

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