CLASS III Drug recall · Reported 26 Jun 2013 · FDA Enforcement Report
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin recalled
Faria Limited is recalling Dr. Sheffield's Triple Antibiotic Ointment Bacitracin, Neomycin Sulfate 5mg, Polymyxin-B, distributed in California, Georgia, Pennsylvania, Washington. The recall was initiated on 28 May 2013 and the FDA has classified it as Class III.
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-604-2013
- FDA event ID
- 65349
- Recalling firm
- Faria Limited, New London, CT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 May 2013
- FDA classified
- 14 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 28 May 2013 | Recall initiated by company | |
| 14 Jun 2013 | Classified by FDA | +17 days |
| 26 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Unable to meet shelf life expiry.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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)
Where it was distributed
PA, GA, WA, CA
Questions about this recall
Is Dr. Sheffield's Triple Antibiotic Ointment Bacitracin, Neomycin Sulfate 5mg, Polymyxin-B recalled?
Yes. Faria Limited recalled Dr. Sheffield's Triple Antibiotic Ointment Bacitracin, Neomycin Sulfate 5mg, Polymyxin-B on 28 May 2013. The recall is Class III and its status is Terminated. Recall number D-604-2013.
Why was it recalled?
Failed Stability Specifications: Unable to meet shelf life expiry.
Which lots are affected?
Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
Where was it sold?
PA, GA, WA, CA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Faria Limited
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dollar General Triple Antibiotic Ointment recalled by Faria Limited | Faria Limited | Sterility | Nationwide |
| Drug | CLASS II | Family wellness Triple Antibiotic Ointment recalled by Faria Limited | Faria Limited | Sterility | Nationwide |
| Drug | CLASS II | Dr. Sheffield Triple Antibiotic Ointment recalled by Faria LimitedSheffield Triple Antibiotic | Faria Limited | Sterility | Nationwide |