The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1076-2014·Announced 2014-02-12

Sheffield Triple Antibiotic Ointment Recalled for Microbial Contamination

Sheffield Pharmaceuticals is recalling Sheffield Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves microbial contamination without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Faria Limited LLC dba Sheffield Pharmaceuticals is recalling Sheffield Triple Antibiotic Ointment (Dr. Sheffield Triple Antibiotic Ointment). The product is an over-the-counter topical ointment containing bacitracin zinc, polymyxin B sulfate, and neomycin sulfate. It is available in 0.33 oz (9g) and 1 oz (22g) sizes.

The recall was initiated because elevated counts of gram-positive rods were found during environmental testing. The source text does not specify the exact number of units affected, the specific distribution locations, or any reported illnesses or injuries associated with the product.

Consumers who have purchased this product should check their lot numbers and expiration dates against the list provided by the manufacturer. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer for instructions on how to return the product or obtain a refund.

The recalled product

Product
SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE)
Brand
SHEFFIELD TRIPLE ANTIBIOTIC
Manufacturer
Faria Limited LLC dba Sheffield Pharmaceuticals
Category
Drug — Topical Antibiotic
Hazard
Affected units
332,508

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 (16)

  • 20154 EXP.12/13
  • 20153 EXP.12/13
  • 20152 EXP.12/12
  • 20151 EXP.12/11
  • 20093 EXP.12/13
  • 20092 EXP.12/13
  • 20091 EXP.12/13
  • 20085 EXP.12/13
  • 20084 EXP.12/13
  • 20083 EXP. 2/13
  • 20082 EXP.12/13
  • 20073 EXP. 12/13
  • 20074 EXP. 12/13
  • 20075 EXP. 12/13
  • 20081 EXP.12/13
  • 20021 EXP. 12/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Faria Limited LLC dba Sheffield Pharmaceuticals 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 3 products in this recall →

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