Agency classClass IIOur severity:High FDA (Drugs)·D-0352-2024·Announced 2024-03-06

Equate Stye Lubricant Eye Ointment recalled due to sterility assurance failure

Equate Stye Lubricant Eye Ointment is being recalled due to lack of assurance of sterility. Approximately 355,633 units have been distributed nationwide and are affected.

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: FDA Class II recall for lack of sterility assurance in an eye ointment. No reported illnesses, but this is a risk-of-harm product where eye infection could occur from non-sterile product, meeting the score-3 criterion.

Plain-English summary

Brassica Pharma Pvt Ltd is recalling Equate Stye Lubricant Eye Ointment due to a lack of assurance of sterility. The recalled product is distributed by Walmart Inc. in 3.5 gram tubes and contains Mineral Oil 31.9% and White Petrolatum 57.7%. Approximately 355,633 units are affected by this recall.

The manufacturer was unable to provide adequate assurance that the product meets sterility requirements. Affected lot numbers include: A2D08 (Exp. Mar-24), A2F02 (Exp. May-24), A2I03 (Exp. Aug-24), A2L03 and A2L04 (Exp. Nov-24), A3C03 and A3C05 (Exp. Feb-25), and A3H01 and A3H03 (Exp. Jul-25). The product was distributed nationwide within the United States.

Consumers who purchased this product should stop using it immediately and return it to Walmart for a full refund.

Anyone who used this product and has concerns should consult with a healthcare provider, particularly if any eye irritation or infection symptoms develop.

The recalled product

Product: Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
Manufacturer: Brassica Pharma Pvt Ltd
Category: Drug — Ophthalmic
Hazard: sterility-failure
Affected units: 355,633

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 (14)

Lot #: A2D08
Exp. Date Mar-24
A2F02
Exp. Date May-24
A2I03
Exp. Date Aug-24
A2L03
A2L04
Exp. Date Nov-24
A3C03
A3C05
Exp. Date Feb-25 A3H01
A3H03
Exp. Date Jul-25

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Brassica Pharma Pvt Ltd 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 4 products in this recall →

Same manufacturer · Brassica Pharma Pvt Ltd

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Same hazard · sterility failure