FDA Recall of Optase Dry Eye Intense Drops Due to Sterility Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has initiated a recall of Optase Dry Eye Intense Drops because of a lack of assurance of sterility, affecting products distributed nationwide in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 12, 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, cpsc, Drugs.
What Happened
The recall was initiated due to a lack of assurance of sterility in the affected eye drops.
Which Products Are Affected
The affected product is Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, with NDC 72972-002-01. It was manufactured for Scope Health Inc. The recall includes lot numbers: 8T98, 9T31, 9T32 with expiration date 30/04/26; 2V13, 2V14, 2V15 with expiration date 30/06/26; 3V35 with expiration date 31/08/26; 3V36, 3V37 with expiration date 30/09/26; 5V45, 5V46, 9V12 with expiration date 31/03/27; and 1X57, 1X70, 1X84 with expiration date 31/05/27. The product was distributed nationwide within the United States, and the recall number is D-0499-2026.
What You Should Do
Consumers who have the affected lots should stop using the product and contact the recalling firm, Scope Health, for further instructions, as the recall was voluntarily initiated by the firm.
Why This Matters
This recall highlights potential risks associated with non-sterile eye drops, which could affect consumer health, and it involves products distributed across the United States.
Source
FDA recall announcement for recall number D-0499-2026.
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 (1,188 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.