The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0364-2020·Announced 2019-11-27

Equate Restore Tears Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling Equate Restore Tears Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the place of purchase.

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 source text identifies the recall as FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility issues in ophthalmic products which carry significant risk of infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Equate Restore Tears Lubricant Eye Drops Twin Pack (NDC 49035-189-49) because of a lack of assurance of sterility. The product is distributed by Walmart Inc. and was sold nationwide in the United States.

The recall affects 557,376 units. Specific lots involved include Lot 17196 (Exp 07/19), Lot 17292 (Exp 09/19), Lot 17355 (Exp 11/19), and Lot 19040 (Exp 02/21). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should stop using the recalled eye drops immediately. They should return the product to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
557,376

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 #: 17196
  • Exp 07/19
  • 17292
  • Exp 09/19
  • 17355
  • Exp 11/19
  • 19040
  • Exp 02/21

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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