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D-0730-2026Class II

MICRO LABS USA INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
MICRO LABS USA INC
Product type
Drug
Status
Ongoing
Report date
2026-08-05
Distribution
Nationwide in the USA.
Firm state
NJ
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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.

Code / lot info

Lot # DLHU0031, Exp Date: 06/30/2027.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →