Apotex Corp. 2025-07-02 Health serious FDA
Health · FDA · Recall #FDA-D-0495-2025
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex… Recall
Issued July 2, 2025 · Apotex Corp.
In July 2025, Apotex Corp. recalled the Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of Assurance of Sterility
What you should do
- 1 Stop using Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Apotex Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Apotex Corp.
- Category
- Health
- Recall date
- July 2, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-D-0495-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Apotex Corp. has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.