Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Recall
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Micro Labs USA Inc. is recalling one lot of Dorzolamide HCl and Timolol Maleate Ophthalmic Solution due to defective containers with broken cap spikes.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Micro Labs USA Inc. initiated a voluntary recall of Dorzolamide HCl and Timolol Maleate Ophthalmic Solution after receiving multiple complaints of broken cap spikes and undeliverable drops.
Which Products Are Affected
The recall affects Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL bottle (NDC 42571-147-26), Lot # DLHU0031, Exp Date: 06/30/2027. The product is manufactured by Micro Labs Limited, India, for Micro Labs USA Inc., Somerset, NJ. Distribution was nationwide in the USA.
What You Should Do
Consumers should stop using the affected product and contact their pharmacist or healthcare provider for alternatives.
Why This Matters
The defective container may prevent proper delivery of the prescription eye medication.
Source
FDA recall number D-0730-2026, report date 20260805.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (850 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.