FDA recall D-0730-2026

Product

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.

Reason for recall

Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2026-07-22

Report date

2026-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0730-2026