Akorn recalls Betaxolol Ophthalmic Solution 0.5% due to microbial contamination in sterile products. Affected lots may pose infection risks if used.
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Akorn is recalling Betaxolol Ophthalmic Solution 0.5% (5 mL dropper bottles) because stability testing found microbial contamination at the 12-month mark. This could lead to eye infections if the product is used after the contamination occurs.
Sterile eye drops were found to have microbial contamination during stability testing at the 12-month time point. This means the product could cause eye infections if used after the contamination occurs.
People with prescriptions for Betaxolol Ophthalmic Solution 0.5% (5 mL dropper bottles) from Akorn. Those using the product for eye conditions are at risk if the product is contaminated.
Check for the carton NDC 17478-705-10 and bottle NDC 17478-705-11. The product was manufactured with lot number 0B61A and expires January 31, 2022.
Look for carton NDC 17478-705-10 and bottle NDC 17478-705-11 on the packaging.
The product was recalled due to microbial contamination found during stability testing at 12 months. It is not safe to use as it could cause eye infections.
The recall record does not specify a remedy, so contact your healthcare provider for advice on safe alternatives.
Check for carton NDC 17478-705-10 and bottle NDC 17478-705-11. The product was manufactured with lot number 0B61A and expires January 31, 2022.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0004-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0004-2022 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
