Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution Solution/ Drops
FDA Recall NDC 42571-147
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution (NDC 42571-147). A significant event, classified as Class II, was initiated on Jul 22, 2026 by Micro Labs Limited. The reported reason for this action was: "Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Jul 22, 2026
Aug 05, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99481
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
MICRO LABS USA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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.
Batch or Lot Expiration Information
Lot# DLHU0031, Exp Date: 06/30/2027.
Affected Packages Involved in this Recall
42571-147-26Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
