GNP redness and dry eye relief drops recalled over sterility assurance
GNP Eye Drops Redness and Dry Eye Relief, containing glycerin and naphazoline hydrochloride, are being recalled for lack of assurance of sterility.
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
GNP Eye Drops Redness and Dry Eye Relief (glycerin, naphazoline hydrochloride) are being recalled. About 315,144 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 product covers lot RL24D01 (expiry 04/30/26) and lots RL24F01 and RL24F02 (expiry 06/30/26), across multiple package configurations listed in the FDA enforcement record.
Consumers and pharmacies can identify affected product by the lot numbers and expiry dates above, and may contact the recalling firm for further information.
The recalled product
- Product
- LEADER EYE DROPS REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE)
- Brand
- LEADER EYE DROPS REDNESS RELIEF
- Manufacturer
- K.C. Pharmaceuticals, Inc
- Category
- Drug — Ophthalmic
- Affected units
- 315,144
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 (15)
- Lot: a) RL24D01
- Exp.: 04/30/26
- RL24F01
- RL24F02
- Exp.:06/30/26
- b) RL24F01
- c) RL24F01
- d) RL24F02
- e) RL24F01
- f) RL24F01
- g) RL24F01
- h) RL24F01
- i) RL24F01
- j) RL24F02
- k)
UPCs (8)
- 0096295137620
- 0096295137637
- 0010939958310
- 348201016155
- 348201016131
- 041163461512
- 311917177410
- 093351034114
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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