Agency classClass IIOur severity:High FDA (Drugs)·D-0351-2024·Announced 2024-03-06

Equate Lubricant Eye Ointment Recalled for Lack of Sterility Assurance

Equate Lubricant Eye Ointment, distributed nationwide by Walmart, is being recalled because the manufacturer cannot assure the product's sterility. The recall affects 315,842 units across multiple lots.

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 ophthalmic medication. No illnesses or hospitalizations reported, placing this at High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Equate Lubricant Eye Ointment is being recalled by the FDA. The product is supplied in 3.5-gram tubes containing Mineral Oil 42.5% and White Petrolatum 57.3%, manufactured by Brassica Pharma Pvt Ltd and distributed nationwide by Walmart Inc.

The recall is due to a lack of assurance of sterility. The FDA has classified this as a Class II recall, indicating that the manufacturer cannot adequately ensure the product meets sterility standards required for ophthalmic medications.

The recall affects 315,842 units distributed nationwide in the United States. The affected lots and expiration dates are: Lot A2E01 (Exp. Apr 2024), Lot A2L05 (Exp. Nov 2024), Lot A3B01 (Exp. Jan 2025), and Lot A3C01 (Exp. Feb 2025). The product is identified by NDC 79903-026-35 and UPC 681131395298.

Consumers who have purchased this product may contact their healthcare provider for guidance. Retailers should remove the product from shelves.

The recalled product

Product: Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298
Manufacturer: Brassica Pharma Pvt Ltd
Category: Drug — Ophthalmic
Hazard: lack-of-sterility
contamination-risk
Affected units: 315,842

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 (8)

Lot #: A2E01
Exp. Date Apr-24
A2L05
Exp. Date Nov-24
A3B01
Exp. Date Jan-25
A3C01
Exp. Date Feb-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 · lack of sterility