The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0412-2020·Announced 2019-11-27

CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Issues

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.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving sterility assurance issues for ophthalmic products which carry significant risk of infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is voluntarily recalling CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief (Item#: 563431, 15 mL) distributed by CVS Pharmacy, Inc. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product was distributed nationwide in the United States. The recall involves 222,096 units with specific lot codes and expiration dates listed in the agency's structured data. The agency 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 who have purchased this product should stop using it immediately. They should return the product to the point of purchase for a refund or contact the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
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 →

Related recalls

Same manufacturer · Altaire Pharmaceuticals, Inc.

See all →

Same hazard · sterility

See all →

Similar recalls