The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0411-2026·Announced 2026-04-08

Artificial tears glycerin drops recalled over lack of sterility assurance

Artificial Tears containing glycerin are being recalled for lack of assurance of sterility. About 1,023,096 bottles were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

Artificial Tears (glycerin) are being recalled. About 1,023,096 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
ARTIFICIAL TEARS (GLYCERIN)
Brand
ARTIFICIAL TEARS
Manufacturer
K.C. Pharmaceuticals, Inc
Category
Drug — Ophthalmic
Hazard
Affected units
1,023,096

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 (20)

  • Lot: a) LT24E01
  • LT24E02
  • LT24E03
  • Exp.: 05/31/26
  • LT24F01
  • Exp.: 06/30/26
  • LT24G01
  • Exp.: 07/31/26
  • LT24M01
  • LT24M02
  • Exp.: 10/31/26
  • b) LT24E03
  • Exp.:06/30/26
  • Exp.:07/31/26
  • c) LT24F01
  • d) LT24F01
  • e) LT24F01
  • f) LT24F01
  • g) LT24F01
  • h) LT24F01

UPCs (12)

  • 0357896184056
  • 0011822106702
  • 0096295137064
  • 0096295137071
  • 0010939958273
  • 0713733296922
  • 036800361003
  • 093351011566
  • 041220437412
  • 095072026560
  • 072036713032
  • 614299056206

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 brand · ARTIFICIAL TEARS

Same manufacturer · K.C. Pharmaceuticals, Inc

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Same hazard · sterility failure

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