Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recall
FDA recall D-0730-2026 · initiated Jul 22, 2026
MICRO LABS USA INC recalled Dorzolamide HCl and Timolol Maleate Ophthalmic Solution in Jul 2026 — an FDA Class II recall (D-0730-2026) because Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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.
- Recalling company
- Micro Labs
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Jul 22, 2026
- FDA report date
- Aug 5, 2026
This recall is linked to a product we cover: Dorzolamide Hydrochloride and Timolol Maleate →
Frequently asked
- Was Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recalled?
- MICRO LABS USA INC recalled Dorzolamide HCl and Timolol Maleate Ophthalmic Solution in Jul 2026 — an FDA Class II recall (D-0730-2026) because Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0730-2026 was: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
- Is a recalled Dorzolamide HCl and Timolol Maleate Ophthalmic Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dorzolamide HCl and Timolol Maleate Ophthalmic Solution are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot # DLHU0031, Exp Date: 06/30/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0730-2026.