The Recall Desk
SevereFDA (Drugs)·D-0396-2020·Announced 2019-11-27

CVS Health Lubricant Eye Drops Recalled for Sterility Concerns

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

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 or property damage reports, or in this case, a critical sterility failure in a sterile product, are classified as Severe (Score 4).

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL). The product is distributed by CVS Pharmacy Inc. The recall is being conducted because of a lack of assurance of sterility.

Approximately 22,209 units of the product were distributed nationwide in the United States. The affected lots include codes 18043, 18115, 18300, and 18116, with expiration dates ranging from February 2020 to December 2020.

Consumers should stop using the recalled eye drops immediately. The product should be returned to the point of purchase for a refund or replaced with a non-recalled item.

The recalled product

Product
CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Affected units
222,096

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 →