The Recall Desk
SevereFDA (Drugs)·D-0388-2020·Announced 2019-11-27

CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Concerns

Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 39,744 units distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe. While specific injury reports are not detailed in the provided text, the agency classification of Class II for a sterility issue in an ophthalmic product aligns with the Severe criteria for significant potential harm.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack (Item #994881, 2 x 10 mL). The recall is being conducted due to a lack of assurance of sterility. The product is distributed by CVS Pharmacy Inc.

The recall affects 39,744 units distributed nationwide in the U.S.A. The specific lots involved are 17296 (10/19), 18094 (04/20), and 18206 (08/20).

Consumers should check their eye drops for the listed lot numbers and stop using the product if it matches. They should contact CVS Pharmacy Inc. or Altaire Pharmaceuticals for further instructions on disposal or return.

The recalled product

Product
CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item #994881 Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Affected units
39,744

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 (1)

  • Lot #: 17296 10/19 18094 04/20 18206 08/20

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 →