July 2026 FDA Recall Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution by Micro Labs Usa Inc
D-0730-2026 - Defective Container

This Class II drug recall was voluntarily initiated by Micro Labs Usa Inc on July 22, 2026 for the product Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0730-2026

Reason for Recall
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Initiated
07-22-2026
Reported
08-05-2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99481
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
MICRO LABS USA INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

42571-147-26 Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution