OVERLOOKED

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Class IIOngoing

MICRO LABS USA INC recalls Dorzolamide HCl and Timolol Maleate Ophthalmic Solution

Recall date · record updated Aug 5, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
MICRO LABS USA INC
Reason
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide in the USA.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99481…

Products

  1. 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.

    Codes/lots: Lot # DLHU0031, Exp Date: 06/30/2027.Quantity: N/ARecall no. D-0730-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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