Apotex recalls 0.05% Azelastine HCl eye drops due to potential lack of sterility. This could cause infections if used improperly. Consumers should contact Apotex for details.
Lack of Assurance of Sterility
Apotex is recalling a prescription eye drop product because it may not be sterile. Using it could lead to eye infections, especially if the bottle is contaminated.
The product may not be sterile, meaning it could contain harmful bacteria. If the bottle is contaminated, using it might cause eye infections or other infections.
Prescription users of this eye drop are affected. Those with compromised immune systems or existing eye conditions may be at higher risk.
Check for the product name 'Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL' on the label. It was manufactured by Apotex Inc. in Toronto, Canada, with batch number VD1654 and expiration date 06/30/2027.
Look for the product name 'Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL' and batch number VD1654.
The recall states there is a risk of lack of sterility, which could cause infections. Do not use the product until you receive further instructions from Apotex.
Check the label for the product name 'Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL' and batch number VD1654.
The recall does not specify a remedy, so contact Apotex directly for guidance on next steps.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-0495-2025 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-0495-2025 from Apotex. 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.
