Akorn recalls Olopatadine HCl Ophthalmic Solution 0.1% 5mL bottles due to manufacturing deviations. This prescription eye drop may not be safe for use. Contact your doctor for guidance.
CGMP Deviations:
Akorn is recalling prescription olopatadine eye drops that were manufactured with CGMP deviations. This means the product may not be safe for use as intended.
The recall is due to CGMP deviations in manufacturing, which means the product may not meet safety and quality standards. However, the specific hazard mechanism is not described in the recall notice.
Prescription eye drop users who have the specific 5mL bottles with NDC 60429-957-05 and lots 1C61A (expiring 2/28/2023) or 1D86A/1D07A (expiring 3/31/2023).
Check for the product name 'Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle' with NDC 60429-957-05 and lots 1C61A (expiring 2/28/2023) or 1D86A/1D07A (expiring 3/31/2023).
Look for the NDC code 60429-957-05 and lot numbers 1C61A, 1D86A, or 1D07A on the bottle.
The recall states there were CGMP deviations in manufacturing, but does not specify if the product is unsafe. Contact your doctor for guidance.
The recall does not provide a remedy, so contact your doctor for advice on whether to stop using it.
The product was manufactured with lot numbers 1C61A (expiring 2/28/2023) or 1D86A/1D07A (expiring 3/31/2023).
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0151-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0151-2023 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.
