The Recall Desk
SevereFDA (Drugs)·D-0406-2020·Announced 2019-11-27

CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

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, an FDA Class II recall involving a significant hazard such as lack of sterility in an ophthalmic product corresponds to a severity score of 4 (Severe).

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Eye Drops Fast Acting (Item #258625, 0.6 mL x 60 ct). The product is distributed by CVS Pharmacy, Inc. The recall involves 39,072 units that were distributed nationwide in the United States.

The recall is being conducted due to a lack of assurance of sterility. The affected lots have the following codes: RHD 08/19, RIF 09/19, RIN 09/19, RKP 11/19, SAR 01/20, SCG 03/20, and SED 5/20.

Consumers who have this product should stop using it and return it to the pharmacy where it was purchased for a refund.

The recalled product

Product
CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Affected units
39,072

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 →