CLASS II ONGOING Drug recall · Reported 5 Aug 2026 · FDA Enforcement Report
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recalled
Micro Labs USA is recalling Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, distributed nationwide in the US. The recall was initiated on 22 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0730-2026
- FDA event ID
- 99481
- Recalling firm
- Micro Labs USA, Somerset, NJ
- Manufacturer
- Micro Labs Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2026
- FDA classified
- 24 Jul 2026
- Reported
- 5 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 22 Jul 2026 | Recall initiated by company | |
| 24 Jul 2026 | Classified by FDA | +2 days |
| 5 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Which lots are affected?
Lot # DLHU0031, Exp Date: 06/30/2027.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.