Class II · Moderate risk Ongoing
Thymosin Beta-4
Reason Lack of Assurance of Sterility
Betaxolol Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
What was recalled
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
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-705-11
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0004-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Beta recalls
See all
Class II · Moderate risk Ongoing
BPC-157/Thymosin Beta-4 for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Labetalol Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Terminated
labetalol HCl 20 mg/4mL Injection
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Betaxolol Tablets
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.