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.
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
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
- 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
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