The Recall Desk

Manufacturer

Akorn, Inc.

128 recalls in our database name Akorn, Inc. as the manufacturing or recalling firm.

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.

126–128 of 128

  • SevereFDA (Drugs)·D-0004-2022·2021-10-13

    Betaxolol Ophthalmic Solution Recalled for Sterility Failure

    Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.

    Product
    Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0802-2021·2021-09-22

    Betamethasone Dipropionate Lotion recalled for unknown impurity

    Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0786-2021·2021-09-08

    Akorn Artificial Tears Ointment Recalled for Non-Sterility

    Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.

    Product
    Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide