North Chicago, IL, United States
AbbVie Inc. recalls
4 recalls recorded since 2018, most recently on 18 May 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 18 May 2026
- Reason
- Failed Stability Specifications
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0551-2026
- PRED 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.
Ongoing Class II Drugs
- Recall started
- 16 September 2024
- Reason
- Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- Distribution
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0664-2024, D-0665-2024
- 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 AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
- Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
Ongoing Class III Drugs
- Recall started
- 17 October 2023
- 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.
- Distribution
- Distributed in the US. No government or foreign consignees.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0088-2024
- Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Terminated Class III Drugs
- Recall started
- 22 January 2018
- Terminated
- 13 September 2018
- Reason
- Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
- Distribution
- MS, OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0412-2018
- Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.