CVS Health Lubricant Eye Ointment recalled due to lack of sterility assurance
CVS Health Lubricant Eye Ointment is being recalled nationwide due to lack of sterility assurance during manufacturing. The recall affects 159,334 units distributed in 3.5-gram tubes with lot numbers A2F03, A2I02, A2L02, A3C04, and A3H04.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile ophthalmic product where sterility assurance failed. No illnesses, injuries, or hospitalizations have been reported. The hazard—potential for eye infection from non-sterile product—is theoretical without documented cases.
Plain-English summary
CVS Health Lubricant Eye Ointment, manufactured by Brassica Pharma Pvt Ltd and distributed by CVS Pharmacy, Inc., is being recalled due to lack of assurance of sterility. The recall affects 159,334 units distributed nationwide in 3.5-gram tubes.
The manufacturer was unable to provide adequate assurance that all units were properly sterilized during production. The specific lot numbers involved are: A2F03 (Exp. May 2024), A2I02 (Exp. Aug 2024), A2L02 (Exp. Nov 2024), A3C04 (Exp. Feb 2025), and A3H04 (Exp. Jul 2025).
Consumers who have purchased this eye ointment should stop using it immediately. If you have used this product and experience any eye irritation, infection, or discomfort, consult a healthcare provider. For more information about the recall, contact CVS Pharmacy or visit https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.
The recalled product
- Product
- CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141
- Manufacturer
- Brassica Pharma Pvt Ltd
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- Affected units
- 159,334
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 (10)
- Lot #: A2F03
- Exp. Date May-24
- A2I02
- Exp. Date Aug-24
- A2L02
- Exp. Date Nov-24
- A3C04
- Exp. Date Feb-25
- A3H04
- Exp. Date Jul-25
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Brassica Pharma Pvt Ltd 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 4 products in this recall →Related recalls
Same manufacturer · Brassica Pharma Pvt Ltd
See all →- HighEquate Stye Lubricant Eye Ointment recalled due to sterility assurance failure
FDA (Drugs) · 2024-03-06
- HighFDA recalls Lubricant PM Ointment due to sterility assurance failure
FDA (Drugs) · 2024-03-06
- HighEquate Lubricant Eye Ointment Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2024-03-06
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SevereCVS Health Lubricant Eye Ointment Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereCVS Lubricant Eye Ointment Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-11-27
- SevereCVS Overnight Lubricating Eye Ointment Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereCVS Health Lubricant Eye Ointment Recalled for Sterility Assurance Issues
FDA (Drugs) · 2019-11-27
- SevereCVS Health Lubricant Eye Drops Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-11-27
- SevereCVS Health Lubricant Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2019-11-27