The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0366-2020·Announced 2019-11-27

Altaire Recalls Equate Eye Gel Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Equate Comfort Gel Lubricant Eye Gel because the product lacks assurance of sterility.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Equate Comfort Gel Lubricant Eye Gel Twin Pack (NDC 49035-197-49) due to a lack of assurance of sterility. The product is distributed by Walmart Inc. and is available in a 2 x 15 mL package size.

The recall involves approximately 469,128 units distributed nationwide in the United States. Affected lots include 17384 (Exp 12/19), 17259 (Exp 08/19), 19002 (Exp 01/21), 19041 (Exp 02/21), 18222 (Exp 09/20), and 18084 (Exp 04/20).

Consumers should stop using the product and check their lot numbers and expiration dates against the list above. If the product matches the recalled lots, consumers should contact Walmart or Altaire Pharmaceuticals for further instructions.

The recalled product

Product
Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
469,128

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 (12)

  • Lot #: 17384
  • Exp 12/19
  • 17259
  • Exp 08/19
  • 19002
  • Exp 01/21
  • 19041
  • Exp 02/21
  • 18222
  • Exp 09/20
  • 18084
  • Exp 04/20

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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