Quality & complianceOfficial

FDA classifies Preferred Pharmaceuticals lidocaine ointment recall as Class II over content uniformity failure

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

The nationwide US recall of Lidocaine Ointment USP, numbered D-0013-2027, was logged in the FDA enforcement report on 14 October 2026 and remains ongoing.

The US Food and Drug Administration has listed a Class II recall of Lidocaine Ointment USP from Preferred Pharmaceuticals, Inc. in its enforcement report, dated 14 October 2026. The recall carries the number D-0013-2027.

The stated reason is failure to meet content uniformity specifications. That points to a problem with how consistently the active ingredient is distributed across units or within the product, although the material available does not describe how the failure was detected or what the test results were.

According to the entry, the recall is ongoing and the product was distributed nationwide in the United States. The text supplied from the FDA page consists almost entirely of search-tool and navigation content, so details such as lot numbers, quantities, strengths, pack sizes and dates of initial firm notification are not available here.

As general context, FDA assigns a Class II classification where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams should note that content uniformity failures in topical semi-solids remain a trigger for US recalls, and review blending and sampling controls accordingly.
  • Repackagers and distributors that handle lidocaine ointment should check their inventory against the full FDA enforcement report entry for lot and code details, which are not included in the material reviewed.
  • Pharmacovigilance teams may wish to monitor for any complaints or adverse event reports linked to the affected product, though the source does not report any.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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