CLASS II Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Bactroban Ointment (mupirocin calcium), 2% tube recalled
GlaxoSmithKline is recalling Bactroban Ointment (mupirocin calcium), 2% tube, distributed nationwide in the US. The recall was initiated on 13 Aug 2015 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-1360-2015
- FDA event ID
- 71920
- Recalling firm
- GlaxoSmithKline, Zebulon, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2015
- FDA classified
- 25 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 13 Aug 2015 | Recall initiated by company | |
| 25 Aug 2015 | Classified by FDA | +12 days |
| 2 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Product as listed by the FDA
Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Which lots are affected?
Lot #: C698039, Exp 03/2016
Where was it sold?
Nationwide and Puerto Rico
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
3 other products · FDA event 71920| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bactroban Cream (mupirocin calcium), 2%, a) tube recalled | GlaxoSmithKline | Other | Nationwide | |
| CLASS II | Mupirocin Calcium Cream, 2%, a) tube recalled by GlaxoSmithKline | GlaxoSmithKline | Other | Nationwide | |
| CLASS II | Bactroban (mupirocin calcium) Nasal Ointment, 2% tube recalled | GlaxoSmithKline | Other | Nationwide |
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Other Bactroban (mupirocin recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bactroban (mupirocin calcium) Nasal Ointment, 2% tube recalled | GlaxoSmithKline | Other | Nationwide |
| Drug | CLASS II | Bactroban Cream (mupirocin calcium), 2%, a) tube recalled | GlaxoSmithKline | Other | Nationwide |