FDA Drug recall D-0730-2026
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India,…
- FDA Drug
- Class II
- ongoing
- Published 2026-08-05
On 2026-08-05 the FDA classified a Class II recall of Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India,… by Micro Labs Usa, citing defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0730-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-22 |
| Published | 2026-08-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Micro Labs Usa |
| Distribution | US |
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
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Identifiers
| ndc | 42571-147-26 |
|---|---|
| code_info | Lot # DLHU0031, Exp Date: 06/30/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0730-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.