Equate Stye Lubricant Eye Ointment recalled due to sterility assurance failure
Equate Stye Lubricant Eye Ointment is being recalled due to lack of assurance of sterility. Approximately 355,633 units have been distributed nationwide and are affected.
What this means for you
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: FDA Class II recall for lack of sterility assurance in an eye ointment. No reported illnesses, but this is a risk-of-harm product where eye infection could occur from non-sterile product, meeting the score-3 criterion.
Plain-English summary
Brassica Pharma Pvt Ltd is recalling Equate Stye Lubricant Eye Ointment due to a lack of assurance of sterility. The recalled product is distributed by Walmart Inc. in 3.5 gram tubes and contains Mineral Oil 31.9% and White Petrolatum 57.7%. Approximately 355,633 units are affected by this recall.
The manufacturer was unable to provide adequate assurance that the product meets sterility requirements. Affected lot numbers include: A2D08 (Exp. Mar-24), A2F02 (Exp. May-24), A2I03 (Exp. Aug-24), A2L03 and A2L04 (Exp. Nov-24), A3C03 and A3C05 (Exp. Feb-25), and A3H01 and A3H03 (Exp. Jul-25). The product was distributed nationwide within the United States.
Consumers who purchased this product should stop using it immediately and return it to Walmart for a full refund.
Anyone who used this product and has concerns should consult with a healthcare provider, particularly if any eye irritation or infection symptoms develop.
The recalled product
- Product
- Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
- Manufacturer
- Brassica Pharma Pvt Ltd
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 355,633
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 (14)
- Lot #: A2D08
- Exp. Date Mar-24
- A2F02
- Exp. Date May-24
- A2I03
- Exp. Date Aug-24
- A2L03
- A2L04
- Exp. Date Nov-24
- A3C03
- A3C05
- Exp. Date Feb-25 A3H01
- A3H03
- 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.
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