Akorn recalls 1% Atropine Sulfate Ophthalmic Solution 2mL bottles due to stability failures. The product may not be safe for eye use after expiration.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Akorn is recalling 1% Atropine Sulfate Ophthalmic Solution 2mL bottles because they failed stability tests. This could mean the solution is unsafe for eye use after the expiration date.
The product failed stability tests, meaning the solution may not be safe for eye use after the expiration date. This could lead to potential eye irritation or other issues if used improperly.
People with prescriptions for this eye drop are affected. Those who have the product and are using it as directed are most at risk.
Check for 2mL bottles labeled 'Atropine Sulfate Ophthalmic Solution, USP 1%'. The product was distributed by Akorn with NDC 17478-215-02 and lot number 081031A, expiring 2/28/2023.
Verify the expiration date on the bottle, which is 2/28/2023 for lot 081031A.
The product failed stability tests and may not be safe for eye use after the expiration date. Do not use if expired.
Look for 2mL bottles labeled 'Atropine Sulfate Ophthalmic Solution, USP 1%' with NDC 17478-215-02 and lot 081031A.
Check the expiration date. If expired, do not use and contact your doctor for alternatives.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0265-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0265-2023 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.
