Quality & complianceOfficial

FDA lists Class II recall of K.C. Pharmaceuticals' Eye Drops MAXIMUM over sterility assurance

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The US enforcement report records an ongoing, nationwide recall of Eye Drops MAXIMUM, citing lack of assurance of sterility.

The US Food and Drug Administration has listed a Class II drug recall of Eye Drops MAXIMUM, made by K.C. Pharmaceuticals, Inc., in its enforcement report dated 14 October 2026. The recall carries the number D-0005-2027.

The stated reason is lack of assurance of sterility. The entry shows the recall as ongoing, with distribution across the United States nationwide.

The material available to VigiEye does not include lot numbers, quantities, expiry dates, the date the firm began the recall or the level of the recall (for example consumer or retail). Nor does it say whether any adverse events have been reported. Readers who need those details should consult the full enforcement report entry.

For context, the FDA assigns Class II to recalls where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is remote.

What it means for your team

  • Quality teams at firms making or contract-filling ophthalmic products may wish to review sterility assurance controls, given the regulator's focus on this failure mode.
  • Distributors, pharmacies and retailers in the US should check stock for Eye Drops MAXIMUM against the full recall record, as the recall is ongoing and covers nationwide distribution.
  • Pharmacovigilance teams should note that the available entry gives no information on adverse events, so any complaint or case-handling decisions need the complete recall details.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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