Akorn recalls Olopatadine HCl Ophthalmic Solution 0.2% 2.5mL bottles due to CGMP deviations. Affected lots expired by 2023. Consumers should contact Akorn for details.
CGMP Deviations:
Akorn is recalling certain olopatadine eye drops because manufacturing quality issues were found. This recall affects prescription eye drops with specific lot numbers and expiration dates. The issue could lead to product failure but does not indicate immediate harm to users.
CGMP deviations mean the manufacturing process did not meet quality standards. This could result in the product not working as intended or being unsafe for use, but the recall does not indicate immediate harm to users.
Prescription eye drop users with the specific lot numbers and expiration dates listed in the recall. People using the product for allergies or eye conditions are most at risk.
Check the product label for the lot number and expiration date. The affected lots include 0L48A (exp 10/31/2022), 0L55A (exp 10/31/2022), 1C75A (exp 2/28/2023), and 1E18A/1E20A (exp 4/30/2023).
Look for the lot number and expiration date on the bottle label to determine if it's affected.
The recall is due to CGMP deviations, which means the manufacturing process did not meet quality standards.
Check the product label for the lot number and expiration date. If it matches the affected lots listed, contact Akorn for instructions.
The recall does not indicate immediate harm, but the product may not work as intended due to manufacturing issues.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0149-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0149-2023 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.
