Over 3 Million Eye Drops Recalled Amid Sterility Concerns

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By HealthDay Staff HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on April 6, 2026.

via HealthDay

MONDAY, April 6, 2026 — More than 3 million bottles of over-the-counter eye drops are being recalled after officials raised concerns about the product's safety.

The U.S. Food and Drug Administration (FDA) said the recall affects 3,111,072 bottles made by K.C. Pharmaceuticals of Pomona, California.

The agency said the recall was issued due to a "lack of assurance of sterility," NBC News reported.

The eye drops were sold under several names, including:

  • Dry Eye Relief Eye Drops
  • Sterile Eye Drops
  • Artificial Tears Sterile Lubricant Eye Drops

    • They were available at major retailers such as CVS, Walgreens and Rite Aid, the FDA said.

    There have been no reports of injuries linked to the drops so far.

    The FDA classified this as a Class II recall, which means the products could cause temporary or medically reversible health problems.

    It’s not yet clear what caused the issue, either.

    The recall includes several types of 0.5-ounce (15 mL) bottles, NBC News reported. Among them:

  • Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl oz (15 mL) bottles
  • Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15mL) bottles
  • Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles

    Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles

  • Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 fl oz (15 mL) bottles

    • A complete list of affected drops and where they were sold is available on the FDA website.

    Sources

  • NBC News, April 3, 2026
  • U.S. Food and Drug Administration, enforcement report, March 3, 2026

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2026-04-07 01:53

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