Akorn recalls Olopatadine HCl eye drops due to manufacturing deviations. Affected lots expired by 2023. Consumers should contact Akorn for details.
CGMP Deviations:
Akorn is recalling Olopatadine HCl eye drops (0.1% solution) because of manufacturing deviations. This could pose a risk to eye health if the product is used after the expiration date.
The product was made with CGMP (Current Good Manufacturing Practice) deviations, which means the quality control process may not have been followed properly. This could lead to potential contamination or incorrect dosage, affecting eye health.
People who purchased the Olopatadine HCl eye drops from Akorn or GSMS, Inc. in the US. Those using the product after the expiration date are at higher risk.
Check the product label for the NDC code 51407-499-05 and lot numbers 1L16A, 1L17A (expiring 10/31/2023), 1M29A (expiring 11/30/2023), or 2A05A (expiring 12/31/2023).
Look for the NDC code 51407-499-05 and lot numbers 1L16A, 1L17A, 1M29A, or 2A05A on the bottle.
The recall is due to CGMP deviations, which may affect quality. The product should not be used after the expiration date.
Check the product label for NDC code 51407-499-05 and lot numbers 1L16A, 1L17A (expiring 10/31/2023), 1M29A (expiring 11/30/2023), or 2A05A (expiring 12/31/2023).
The recall does not specify a remedy, so contact Akorn directly for instructions.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0150-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0150-2023 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.