Abbvie recalls

Abbvie appears in 20 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-03.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicag…
  FDA Drug · Class III · 2026-06-03 · Abbvie
  Reason: Failed Stability Specifications
• Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allerg…
  FDA Drug · Class II · 2024-10-02 · Abbvie
  Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
• Refresh 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…
  FDA Drug · Class II · 2024-10-02 · Abbvie
  Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
• Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc
  FDA Drug · Class III · 2023-11-15 · Abbvie
  Reason: 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.
• Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
  FDA Drug · Class III · 2018-02-07 · Abbvie
  Reason: Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
• AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton
  FDA Drug · Class III · 2017-11-01 · Abbvie
  Reason: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
• AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Onl…
  FDA Drug · Class III · 2017-11-01 · Abbvie
  Reason: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
• AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only
  FDA Device · Class II · 2017-06-07 · Abbvie
  Reason: 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.
• AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only
  FDA Device · Class II · 2017-06-07 · Abbvie
• AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only
  FDA Device · Class II · 2017-06-07 · Abbvie
  Reason: 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.
• Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., Nor…
  FDA Drug · Class II · 2017-03-08 · Abbvie
  Reason: 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…
• AbbVie PEG Kit 20 FR
  FDA Device · Class II · 2016-12-28 · Abbvie
  Reason: 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.
• Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc
  FDA Drug · Class III · 2016-04-27 · Abbvie
  Reason: Failed Content Uniformity Specifications
• CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 Capsule Bottles, Rx Only
  FDA Drug · Class II · 2014-10-08 · Abbvie
  Reason: Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
• LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for…
  FDA Drug · Class II · 2014-05-07 · Abbvie
  Reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
• Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-mo…
  FDA Drug · Class II · 2014-05-07 · Abbvie
  Reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
• Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-mon…
  FDA Drug · Class II · 2014-05-07 · Abbvie
  Reason: Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
• Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-mont…
  FDA Drug · Class II · 2014-05-07 · Abbvie
  Reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
• Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 mg for 3-M…
  FDA Drug · Class II · 2014-05-07 · Abbvie
  Reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
• Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories,…
  FDA Drug · Class III · 2013-08-28 · Abbvie
  Reason: Labeling: Incorrect Package Insert; product packaged with outdated version of the insert