The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0399-2020·Announced 2019-11-27

Altaire Recalls Equate Eye Drops Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Equate Eye Allergy Relief Drops because the company cannot ensure the product is sterile.

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: The recall involves a risk-of-harm product (eye drops) where sterility cannot be assured, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Equate Eye Allergy Relief Drops (15 mL) distributed by Wal-Mart Stores, Inc. The recall involves 2,042,136 units sold nationwide in the United States.

The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility issue or report any specific illnesses or injuries associated with the product.

Consumers should stop using the recalled eye drops and return them to the place of purchase for a refund or follow instructions provided by the recalling firm. The affected lot codes are listed in the official recall notice.

The recalled product

Product
Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
2,042,136

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 134 recalled by Altaire 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 134 products in this recall →

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