Original Eye Drops (K.C. Pharmaceuticals) – Manufacturing Documentation (2023)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 1673
Brand
K.C. Pharmaceuticals, Inc
Lot Codes / Batch Numbers
Lot #: a) RG21F01, Exp: 6/30/2023, b) RG21F01, Exp: 6/30/2023, c) RG21F01, Exp: 6/30/2023, d) RG21F01, RG21F02, Exp 6/30/2023, e) RG21F02, RG21F03, Exp 6/30/2023, f) RG21F02, Exp 6/30/2023, g) RG21F02, Exp 6/30/2023, h) RG21F02, Exp 6/30/2023, i) RG21F02, Exp 6/30/2023, j) RG21F02, Exp 6/30/2023, k) RG21F02, Exp 6/30/2023, l) RG21F02, Exp 6/30/2023, m) RG21F03, Exp 6/30/2023, n) RG21F03, Exp 6/30/2023, o) RG21F03, Exp 6/30/2023, p) RG21F03, Exp 6/30/2023
Products Sold
Lot #: a) RG21F01, Exp: 6/30/2023; b) RG21F01, Exp: 6/30/2023; c) RG21F01, Exp: 6/30/2023; d) RG21F01, RG21F02, Exp 6/30/2023; e) RG21F02, RG21F03, Exp 6/30/2023; f) RG21F02, Exp 6/30/2023; g) RG21F02, Exp 6/30/2023; h) RG21F02, Exp 6/30/2023; i) RG21F02, Exp 6/30/2023; j) RG21F02, Exp 6/30/2023; k) RG21F02, Exp 6/30/2023; l) RG21F02, Exp 6/30/2023; m) RG21F03, Exp 6/30/2023; n) RG21F03, Exp 6/30/2023; o) RG21F03, Exp 6/30/2023; p) RG21F03, Exp 6/30/2023
K.C. Pharmaceuticals, Inc is recalling Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed b due to CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026