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Class II · ModerateActive recall

Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # DLHU0031, Exp Date: 06/30/2027.
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMicro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873 foreign manufacturer
Brand nameDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
Generic nameDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Active ingredient(s)DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE
Distributed by / forMicro Labs USA Inc., Somerset, NJ 08873
NDC42571-147-26
Show the full FDA record
Full product labelDorzolamide 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.
Recalling firmMICRO LABS USA INC
DistributionNationwide in the USA.
QuantityN/A
Recall initiated2026-07-22
Report date2026-08-05
Recall completed
Recall numberD-0730-2026
ClassificationClass II
FDA statusOngoing
Origin on fileSomerset NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.