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.

FDA recall notice · announced August 5, 2026 · Micro Labs

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot # DLHU0031, Exp Date: 06/30/2027.
Quantity: N/A
Status: Ongoing
Products in this recall event:
- 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. ND (D-0730-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.