Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0898-2023·Announced 2023-07-19

Eye drops Equate and private-label brands recalled for manufacturing documentation deficiency

K.C. Pharmaceuticals is recalling 397,430 bottles of Equate and private-label dry eye relief drops nationwide due to Current Good Manufacturing Practice deficiencies related to fill line documentation.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for Current Good Manufacturing Practice deficiency regarding fill line documentation. No illnesses or specific product contamination have been reported; the recall addresses a manufacturing process control gap rather than a confirmed safety hazard.

Plain-English summary

K.C. Pharmaceuticals, Inc. is recalling 397,430 bottles of Equate Eye Drops Dry Eye Relief and related private-label versions distributed nationwide. The recalled products are lubricant eye drops containing glycerin, hypromellose, and polyethylene glycol 400.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer identified deficiencies related to a lack of documentation of the fill line during production.

The affected products were distributed under multiple brand names including Equate, DG Health, Sunmark, TopCare Health, HealthMart, Exchange Select, Meijer, H.E.B, and GeriCare. The affected lot numbers are LT21F02 and LT21F03, both expiring in June 2023.

The recalled product

Product: EQUATE EYE DROPS DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400)
Brand: EQUATE EYE DROPS DRY EYE RELIEF
Manufacturer: K.C. Pharmaceuticals, Inc
Category: Drug — Ophthalmic
Hazard: cgmp-deviation
documentation-gap
Affected units: 397,430

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 (11)

Lot #: a) LT21FO2
LT21F03
Exp 6/2023
b) LT21FO2
c) LT21FO2
d) LT21FO2
e) LT21F02
f) LT21F02
g) LT21F03
h) LT21F03
i) LT21F03

UPCs (13)

0681131349864
0010939167330
0713733296922
0357896184056
681131367011
095072026560
010939621443
036800361003
052569137154
614299056206
713733296922
041220437412
357896184056

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · K.C. Pharmaceuticals, Inc

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Same hazard · cgmp deviation