Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram t...

FDA Drug Recall #D-0351-2024 — Class II — January 30, 2024

Recall Summary

Recall Number D-0351-2024
Classification Class II — Moderate risk
Date Initiated January 30, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Brassica Pharma Pvt Ltd
Location Thane
Product Type Drugs
Quantity 315,842 units

Product Description

Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Lot / Code Information

Lot #: A2E01, Exp. Date Apr-24; A2L05, Exp. Date Nov-24, A3B01, Exp. Date Jan-25; A3C01, Exp. Date Feb-25

Other Recalls from Brassica Pharma Pvt Ltd

Recall # Classification Product Date
D-0353-2024 Class II CVS Health Lubricant Eye Ointment (Mineral oil ... Jan 30, 2024
D-0354-2024 Class II Lubricant PM Ointment (Mineral Oil 42.5% and Wh... Jan 30, 2024
D-0352-2024 Class II Equate Stye Lubricant Eye Ointment (Mineral Oil... Jan 30, 2024

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.