The Recall Desk

Manufacturer

AbbVie Inc.

20 recalls in our database name AbbVie Inc. as the manufacturing or recalling firm.

What the numbers show

Total
20
Critical
0
Severe
2
Most recent
2026-06-03

Of the 20 recalls from AbbVie Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–20 of 20

  • ModerateFDA (Drugs)·D-0551-2026·2026-06-03

    Pred Mild prednisolone eye suspension failed stability specifications

    Pred Mild prednisolone acetate ophthalmic suspension 0.12% is being recalled after failing stability specifications. 2,736 bottles are affected.

    Product
    PRED MILD — PRED MILD (PREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0665-2024·2024-10-02

    Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach

    Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0664-2024·2024-10-02

    FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach

    AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.

    Product
    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,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2024·2023-11-15

    Synthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling

    AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0033-2018·2017-11-01

    AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse

    AbbVie is recalling specific lots of AndroGel testosterone gel because prolonged exposure to temperatures outside labeled storage conditions may have affected the product.

    Product
    AndroGel (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: 0051-8462-33
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0034-2018·2017-11-01

    AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse

    AbbVie is recalling 48 cartons of AndroGel testosterone gel distributed in Arizona due to prolonged exposure to temperatures outside labeled storage conditions.

    Product
    AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2176-2017·2017-06-07

    AbbVie Recalls 673 PEG Kits Due to Sterility Concerns

    AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.

    Product
    AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2177-2017·2017-06-07

    AbbVie Recalls PEG Kits Due to Missing or Duplicate Components

    AbbVie is recalling specific lots of PEG Kits due to potential defects including missing components, duplicate parts, or missing labels and instructions.

    Product
    AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2017·2017-06-07

    AbbVie Recalls PEG Kits Due to Missing or Duplicate Components

    AbbVie is recalling 3,331 PEG kits distributed in the US and 31 other countries because they may have missing components, duplicate parts, or missing labels.

    Product
    AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2017·2016-12-28

    AbbVie Recalls 20 FR PEG Kits Due to Disconnection Reports

    AbbVie is issuing an urgent field correction for 20 FR PEG Kits due to increased reports of tube disconnections from Y-connectors.

    Product
    AbbVie PEG Kit 20 FR
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1287-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection

    AbbVie is recalling 7,362 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1291-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits Due to Defective Needle Protection Device

    AbbVie is recalling 2,915 Lupron Depot kits because the syringe needle protection device may be defective. The recall covers nationwide distribution and Puerto Rico.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1290-2014·2014-05-07

    AbbVie Recalls Lupron Depot Kits With Defective Needle Protection

    AbbVie is recalling 1,530 Lupron Depot kits because some may contain a syringe with a defective needle stick protection device.

    Product
    LUPRON DEPOT — LUPRON DEPOT (LEUPROLIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-901-2013·2013-08-28

    AbbVie Recalls Mavik Trandolapril Tablets Due to Outdated Package Insert

    AbbVie is recalling 704 bottles of Mavik trandolapril tablets 4mg because they were packaged with an outdated version of the package insert.

    Product
    Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

AbbVie

pharmaceutical company

Country
United States
Founded
2012

Official website

Source: Wikidata (Q14662364), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.