South Florida drug company recalls 3 eye drugs that might not be sterile |

A South Florida drug maker recalled 199,584 bottles of three ophthalmic solutions because of a “lack of assurance on sterility.”

That’s from FDA alert that the recalls from Apotex’s Weston facility were classified Wednesday as Class II recalls, meaning the recalled items “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The FDA said Apotex didn’t issue a press release on May 28 when it made the actual recalls of the following products.

▪ Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, 105,456 bottles from batch No. VD1654, expiration 06/30/2027.

The label for recalled Azelastine HCl Ophthalmic Solution

▪ Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, 87,840 bottles from batch No. TZ1236, expiration date, 11/30/2025.

The label for recalled Ketorolac Tromethamine Ophthalmic Solution.

▪ Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, 6,288 bottles from batch No. VC6058, expiration date 10/31/2025.

The label for recalled Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution.

If you have any of these, return them the pharmacist for a replacement or refund.

If you suffer a medical problem from the above recalled drugs, contact a medical professional first. Then, reach out to the FDA through the MedWatch Adverse Event reporting system. Third, contact Apotex by emailing drug.safety@apotex.com or calling 416-401-7780.

David J. Neal

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Aaron Moody is a sports and general reporter for the News & Observer. Here is a second sentence for the bio because it will probably be longer than this. Maybe even longer I don't know. Support my work with a digital subscription

This story was originally published June 26, 2025 at 9:17 AM