CLASS II Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report

Bactroban (mupirocin calcium) Nasal Ointment, 2% tube recalled

GlaxoSmithKline is recalling Bactroban (mupirocin calcium) Nasal Ointment, 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

Lot, batch or date codesLot #: C704202, Exp 11/2016; Lot #: C706532, Exp 12/2016; Lot #: C713177, Exp 1/2017; Lot #: C716567, Exp 2/2017, Lot #: C720097, C720098, Exp 3/2017, Expanded to include: C720096, Exp. 2/2017.

Quantity recalled88,489 tubes

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-1359-2015
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: Nasal Sprays

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 (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11

Where it was distributed

Nationwide and Puerto Rico

Nationwide 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 #: C704202, Exp 11/2016; Lot #: C706532, Exp 12/2016; Lot #: C713177, Exp 1/2017; Lot #: C716567, Exp 2/2017, Lot #: C720097, C720098, Exp 3/2017, Expanded to include: C720096, Exp. 2/2017.

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

This product is part of a recall event; the main page for the event is Bactroban Ointment (mupirocin calcium), 2% tube recalled.

Reported	Class	Recall	Company	Reason	Where
2 Sep 2015	CLASS II	Bactroban Ointment (mupirocin calcium), 2% tube recalled	GlaxoSmithKline	Other	Nationwide
2 Sep 2015	CLASS II	Bactroban Cream (mupirocin calcium), 2%, a) tube recalled	GlaxoSmithKline	Other	Nationwide
2 Sep 2015	CLASS II	Mupirocin Calcium Cream, 2%, a) tube recalled by GlaxoSmithKline	GlaxoSmithKline	Other	Nationwide

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Other Bactroban (mupirocin recalls

All 3

Reported	Class	Recall	Company	Reason	Where
2 Sep 2015Drug	CLASS II	Bactroban Cream (mupirocin calcium), 2%, a) tube recalled	GlaxoSmithKline	Other	Nationwide
2 Sep 2015Drug	CLASS II	Bactroban Ointment (mupirocin calcium), 2% tube recalled	GlaxoSmithKline	Other	Nationwide