Drugs & medicalClass II

Akorn, Inc. recalls Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc.,…

Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.

Read the official notice →
Date
2021-10-13
Country
United States
Brand
Akorn
Product
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc.,…
Classification
Class II
Units
Distributed Nationwide in the USA
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Akorn recalls

  1. 2022-07-06
  2. US
    Drugs & medicalClass II

    Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL…

    Defective container: defect prevents product from dispensing as intended.

    FDA · DrugAkorn, Inc.Nationwide USAOfficial notice →
  3. US
    Drugs & medicalClass II

    Akorn, Inc. recalls Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC.,…

    Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

    FDA · DrugAkorn, Inc.Nationwide in the U.S.Official notice →
  4. 2022-05-11
  5. US
    Drugs & medicalClass III

    Akorn, Inc. recalls Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc.…

    Failed viscosity specification - product was below specificcation

    FDA · DrugAkorn, Inc.Nationwide USA and Puerto RicoOfficial notice →
  6. 2022-03-30
  7. US
  8. 2022-01-19
  9. US
    Drugs & medicalClass II

    Akorn, Inc. recalls Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit…

    Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.

    FDA · DrugAkorn, Inc.Nationwide in the USAOfficial notice →
  10. US
All 14 Akorn recalls →

Other drugs & medical recalls in the United States

  1. 2021-10-13
  2. US
    Drugs & medicalClass II

    Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion…

    There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

    FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the state of…Official notice →
  3. US
    Drugs & medicalClass II

    Bard Peripheral Vascular Inc recalls REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.

    FDA · DeviceBard Peripheral Vascular IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →
  4. US
  5. US
    Drugs & medicalClass I

    Azurity Pharmaceuticals, Inc. recalls Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g…

    Product Mix-up: Incorrect diluent component included in the kit.

    FDA · DrugAzurity Pharmaceuticals, Inc.USA nationwideOfficial notice →
  6. US
    Drugs & medicalClass II

    AMIVAS (US), LLC recalls Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials…

    Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.

    FDA · DrugAMIVAS (US), LLCProduct was distributed to 3 major distributors who may have further…Official notice →
  7. US
    Drugs & medicalClass I

    Alpha-Tek LLC recalls ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6.…

    Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

    FDA · DrugAlpha-Tek LLCNationwide in the USOfficial notice →
See all drugs & medical recalls →