Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro La
Summary
The FDA issued a Class II for Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bo by MICRO LABS USA INC. Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops..
Details
Source
Drug Recall
External ID
D-0730-2026
Action Date
2026-08-05
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot # DLHU0031, Exp Date: 06/30/2027.
Quantity Affected: N/A
Reason for Recall
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-22
Company
Somerset, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 63 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MICRO LABS USA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MICRO LABS USA INC have FDA actions?
This is the only FDA action we have on record for MICRO LABS USA INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0730-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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