CLASS II ONGOING Drug recall · Reported 6 Mar 2024 · FDA Enforcement Report
CVS Health Lubricant Eye Ointment (Mineral oil 9% Emollient recalled
Brassica Pharma Pvt is recalling CVS Health Lubricant Eye Ointment (Mineral oil 9% Emollient, White petrolatum 7%, distributed nationwide in the US. The recall was initiated on 30 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0353-2024
- FDA event ID
- 93885
- Recalling firm
- Brassica Pharma Pvt, Thane
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jan 2024
- FDA classified
- 28 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 30 Jan 2024 | Recall initiated by company | |
| 28 Feb 2024 | Classified by FDA | +29 days |
| 6 Mar 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Stores named: CVS
Questions about this recall
Is CVS Health Lubricant Eye Ointment (Mineral oil 9% Emollient, White petrolatum 7% recalled?
Yes. Brassica Pharma Pvt recalled CVS Health Lubricant Eye Ointment (Mineral oil 9% Emollient, White petrolatum 7% on 30 Jan 2024. The recall is Class II and its status is Ongoing. Recall number D-0353-2024.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
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
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Brassica Pharma Pvt
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Equate Stye Lubricant Eye Ointment (Mineral Oil recalled | Brassica Pharma Pvt | Sterility | Nationwide |
| Drug | CLASS II | Lubricant PM Ointment (Mineral Oil 5% and White Petrolatum 3%) recalled | Brassica Pharma Pvt | Sterility | Nationwide |
| Drug | CLASS II | Equate Lubricant Eye Ointment (Mineral Oil 5%, White Petrolatum 3%) recalled | Brassica Pharma Pvt | Sterility | Nationwide |
Other Cvs health lubricant eye recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | CVS Health Lubricant Eye Ointment Sensitive Formula recalled | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile recalled | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | CVS Health Lubricant Eye Drops recalled by Altaire Pharmaceuticals | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack recalled | Altaire Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | CVS Health Lubricant Eye Ointment Sensitive Formula recalled | Altaire Pharmaceuticals | Sterility | Nationwide |