CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Dr. Sheffield Triple Antibiotic Ointment recalled by Faria Limited
Faria is recalling Dr. Sheffield Triple Antibiotic Ointment, distributed nationwide in the US. The recall was initiated on 22 Nov 2013 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-1076-2014
- FDA event ID
- 66962
- Recalling firm
- Faria, New London, CT
- Manufacturer
- Sheffield Pharmaceuticals LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2013
- FDA classified
- 5 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 22 Nov 2013 | Recall initiated by company | |
| 5 Feb 2014 | Classified by FDA | +75 days |
| 12 Feb 2014 | 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
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
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
Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Which lots are affected?
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
Where was it sold?
Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 66962| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Family wellness Triple Antibiotic Ointment recalled by Faria Limited | Faria | Sterility | Nationwide | |
| CLASS II | Dollar General Triple Antibiotic Ointment recalled by Faria Limited | Faria | Sterility | Nationwide |
More recalls from Faria
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dollar General Triple Antibiotic Ointment recalled by Faria Limited | Faria | Sterility | Nationwide |
| Drug | CLASS II | Family wellness Triple Antibiotic Ointment recalled by Faria Limited | Faria | Sterility | Nationwide |
| Drug | CLASS III | Dr. Sheffield's Triple Antibiotic Ointment Bacitracin recalled | Faria | Potency & Assay | 4 states |
Other Bacitracin Zinc recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rapidol, Triple Antibiotic First Aid Ointment recalledRapidol | Kenil Healthcare Private | Manufacturing (CGMP) Deviations | DE, NC |