DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
Recalling Firm / Manufacturer: MICRO LABS USA INC
(Somerset, NJ, United States)
FDA Recall Number: D-0730-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
Generic Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Active Substance(s)
Dorzolamide Hydrochloride, Timolol Maleate
Administration Route
Ophthalmic
National Drug Code (NDC)
42571-147
Total Quantity Recalled
N/A
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
August 05, 2026
Firm Initiation Date
July 22, 2026
FDA Classification Date
Jul 24, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # DLHU0031, Exp Date: 06/30/2027.
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0730-2026
Questo Retrieval Date: September 10, 2026 12:00 1789041611UTCC