The Recall Desk
HighFDA (Drugs)·D-0416-2026·Announced 2026-04-08

Leader artificial tears 15 mL recalled over sterility assurance failure

Leader Artificial Tears 15 mL, containing polyvinyl alcohol and povidone, are being recalled for lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a sterile ophthalmic product whose sterility cannot be assured, with no injuries stated.

Plain-English summary

Leader Artificial Tears 15 mL (polyvinyl alcohol, povidone) are being recalled. About 589,848 bottles were distributed nationwide in the United States. The FDA has classified this recall as Class II.

The recall was initiated for lack of assurance of sterility.

Affected lots are listed in the FDA enforcement record.

Consumers and pharmacies can identify affected product by the lot numbers printed on the pack, and may contact the recalling firm for further information.

The recalled product

Product
LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE)
Brand
LEADER ARTIFICIAL TEARS 15 ML
Manufacturer
K.C. Pharmaceuticals, Inc
Category
Drug — Ophthalmic
Hazard
Affected units
589,848

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Lot: a) AT24D01
  • Exp.: 04/30/26
  • AT24E01
  • Exp.: 05/31/26
  • AT24G01
  • Exp.: 07/31/26
  • b) AT24D01
  • AT24E02
  • c) AT24D01
  • d) AT24D01
  • e) AT24E01
  • f) AT24E01
  • g) AT24E02
  • Exp.: 05/31/26.

UPCs (8)

  • 0096295137644
  • 0180410000163
  • 0087701104060
  • 0635515992238
  • 036800093317
  • 070038470083
  • 011110386007
  • 041415009769

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by K.C. Pharmaceuticals, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · K.C. Pharmaceuticals, Inc

See all →

Same hazard · sterility failure

See all →