The Recall Desk
HighFDA (Drugs)·D-0676-2025·Announced 2025-10-08

[pending] BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)

Pending LLM rewrite. Source: FDA_DRUG D-0676-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

The recalled product

Product
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
Brand
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Manufacturer
Apotex Corp.

Distribution

Distributed nationwide across the United States.