PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported September 2, 2015

Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Recall #
D-1361-2015
Affected scope
28,480 tubes of 15g, 12,234 tubes of 30g
Initiated
August 13, 2015
Verify with FDA Drug →
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GlaxoSmithKline, LLC. recalled Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (ND… - a moderate-severity action.

Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (ND… was recalled by GlaxoSmithKline, LLC. in September 2, 2015. Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin a…. Check the official notice for the remedy. Verify recall #D-1361-2015 with the FDA Drug before acting.

The recall

GlaxoSmithKline, LLC. issued this moderate-severity FDA Drug recall-Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin a….

Moderate
severity level
Class II
classification
September 2, 2015
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1361-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Cosmetics & Personal Care recalls over time

Where this recall sits in its category - 1,371 cosmetics & personal care recalls on record

0100200300400 20052008201120142017202020232026 33
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.

Reason for recall

Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-1361-2015
Date reported September 2, 2015
Date initiated August 13, 2015
Recalling firm GlaxoSmithKline, LLC.
Firm location Zebulon, NC
Affected scope 28,480 tubes of 15g, 12,234 tubes of 30g
Distribution Nationwide and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-1361-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.. Recalled by GlaxoSmithKline, LLC.. Units affected: 28,480 tubes of 15g, 12,234 tubes of 30g.
Why was this product recalled?
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2015. Severity: Moderate. Recall number: D-1361-2015.
Where was the recalled product distributed?
Distribution: Nationwide and Puerto Rico.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 7… → · All Cosmetics & Personal Care recalls

This recall: FDA Drug, reported September 2, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026