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Class II: temporary or reversible health riskOngoing

Micro Labs Dorzolamide HCl and Timolol Maleate Recall

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0

MICRO LABS USA INC · Somerset, NJ

Risk level
Class II
Reported by FDA
Aug 5, 2026
Recall ID
D-0730-2026
Check your lot numberHow we source this data

Summary

Micro Labs recalled Dorzolamide HCl and Timolol Maleate starting Jul 22, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0730-2026 on Aug 5, 2026. Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. Status: Ongoing.

Why it was recalled

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0730-2026
Classification
Class II
Status
Ongoing
Recall initiated
Jul 22, 2026
FDA report date
Aug 5, 2026
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
MICRO LABS USA INC

Original FDA data

Every field from FDA enforcement report D-0730-2026, exactly as published.

Show all FDA fields
City
Somerset
State
NJ
Status
Ongoing
Country
United States
Event ID
99481
Address
220 Davidson Ave
Code information
Lot # DLHU0031, Exp Date: 06/30/2027.
Postal code
08873-4149
Report date
Aug 5, 2026
Product type
Drugs
Recall number
D-0730-2026
Classification
Class II
Recalling firm
MICRO LABS USA INC
Reason for recall
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA.
Recall initiation date
Jul 22, 2026
Initial firm notification
Letter
Center classification date
Jul 24, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0730-2026, published Aug 5, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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