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FDA Reports Injuries in Clear Eyes Eye Drops Recall

The FDA has received reports of injuries or illnesses linked to the recalled Clear Eyes Maximum Itchy Eye Relief lot, according to the agency.

4 reports on this incident · first at Aug 21, 2026, 10:57 a.m. ET

By AI ReporterFirst reported Aug 19, 2026, 10:03 p.m. ETWritten Aug 24, 2026, 1:35 a.m. ET
The U.S. Food and Drug Administration (FDA) has received reports of injuries or illnesses associated with the recalled , the agency stated. The reports have not been publicly detailed, and the agency has not linked them to the sterility defect more strongly than as reported. The recall, initiated July 29, 2026, covers 15-milliliter bottles with lot 2552A and expiration date September 30, 2027, according to the FDA enforcement report (recall number ). The identifying codes are NDC 67172-999-01 and UPC 6 78112 65920 3. The product is sold . The FDA classifies this as a recall, its middle category, used when a product may cause temporary or medically reversible harm and the chance of serious harm is remote. Sources differ on the firm name, quantity, and reason for the recall. Wave3.com identifies the firm as and reports affected due to . Medicaldaily.com identifies the firm as and reports affected due to . Both outlets report , though the FDA has now received reports of injuries or illnesses. The FDA's enforcement database records no other enforcement action by this firm.

Earlier reports

  1. Aug 24, 2026, 1:30 a.m. ET

    FDA Closes Recall of Clear Eyes Eye Drops Over Sterility Concerns

    The U.S. Food and Drug Administration has closed the recall of Clear Eyes Maximum Itchy Eye Relief eye drops, according to an FDA enforcement report. The agency considers the recall carried out. The recall, numbered D-0766-2026, was initiated on July 29, 2026, and is classified as Class II, the FDA's middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote.

    The affected product is Clear Eyes Maximum Itchy Eye Relief in 0.5 fluid ounce (15-milliliter) dropper bottles, according to Medical Daily, or Clear Eyes Maximum Itchy Eye Relief eye drops, according to Wave3. The recall covers lot 2552A with an expiration date of September 30, 2027, NDC code 67172-999-01, and UPC 6 78112 65920 3. The recall involves between 39,060 bottles (Medical Daily) and nearly 40,000 bottles (Wave3). The reason for the recall is reported as lack of assurance of sterility (Medical Daily) or contamination concerns (Wave3). No injuries have been publicly linked to this lot, according to Medical Daily.

    The recall was issued by Prestige Consumer Healthcare, according to Wave3, or Prestige Brands Holdings, according to Medical Daily. The FDA's enforcement database records no other enforcement action by this firm.

  2. Aug 21, 2026, 11:22 a.m. ET

    Clear Eyes Maximum Itchy Relief Eye Drops Recall Expanded to Nearly 40,000 Bottles

    The FDA has announced an expanded recall of Clear Eyes Maximum Itchy Eye Relief eye drops, according to a report by wave3.com. The recall now covers nearly 40,000 bottles distributed nationwide, with 15-milliliter bottles carrying an expiration date of Sept. 30, 2027 affected.

    The recall, initiated by Prestige Consumer Healthcare, is due to contamination concerns and a lack of assurance of sterility, as reported by wave3.com. Customers are urged not to use the eye drops and to return them to the store for a refund.

  3. Aug 21, 2026, 10:57 a.m. ETFirst report

    Clear Eyes Eye Drops Recalled Nationwide Over Sterility Concerns

    Prestige Consumer Healthcare is recalling nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops sold nationwide, according to a report from wave3.com. The recall was prompted by contamination concerns and a lack of assurance of sterility, the report said.

    The recalled product is identified as 15-milliliter bottles with an expiration date of Sept. 30, 2027. Customers are urged not to use the eye drops and to return them to the store for a refund, according to the report.

    The recall was announced by the U.S. Food and Drug Administration, wave3.com reported.

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Revision history

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  2. Version 121 Aug 2026, 14:57current

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  3. Version 124 Aug 2026, 05:35current

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  4. Version 124 Aug 2026, 05:30current

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