Triple Antibiotic Ointment (Sheffield Pharmaceuticals) – Stability Failure (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)
Brand
Faria Limited LLC dba Sheffield Pharmaceuticals
Lot Codes / Batch Numbers
Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
Products Sold
Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
Faria Limited LLC dba Sheffield Pharmaceuticals is recalling Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B due to Failed Stability Specifications: Unable to meet shelf life expiry.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Stability Specifications: Unable to meet shelf life expiry.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, PA, WA
Page updated: Jan 7, 2026