FDAFDA recall D-0730-2026 · Aug 5, 2026
MICRO LABS USA INC: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recall
Recall found
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.
Reason for recall
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # DLHU0031, Exp Date: 06/30/2027.
- Quantity
- N/A
- Distribution
- Nationwide in the USA.
- Recalling firm
- MICRO LABS USA INC, Somerset, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-22
Source: openFDA enforcement record D-0730-2026 · search recall number D-0730-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.