Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recall (MICRO LABS USA INC)
DrugClass IIOngoing
Summary: MICRO LABS USA INC is recalling 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.. Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
What is being recalled
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.
Why
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot # DLHU0031, Exp Date: 06/30/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0730-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 22, 2026 |
| Reported | August 5, 2026 |
| Company | MICRO LABS USA INC |
| Company location | Somerset, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
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