Quality & complianceOfficial

FDA lists Class II recall of Direct Rx lidocaine ointment over subpotency

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

An FDA enforcement report entry classifies the Direct Rx Lidocaine Ointment USP recall as Class II for subpotency; the recall is ongoing and covers the whole US.

The US Food and Drug Administration has published an enforcement report entry for a Class II recall of Lidocaine Ointment USP handled by Direct Rx. It is listed under recall number D-0107-2027, and the item is dated 4 November 2026.

The reason for the recall is given as subpotency. In general, this means a product may contain less active ingredient than its labelling states. The entry lists the recall status as ongoing, and distribution as nationwide within the United States.

Under FDA's classification system, a Class II recall covers products that may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious harm is remote.

The material available does not give lot numbers, product strengths, quantities, or the dates of the recall's initiation. Those details sit in the full enforcement report record.

What it means for your team

  • Quality teams at repackagers and relabellers should check whether any affected lidocaine ointment is in their supply chain, using the full FDA record for product and lot details.
  • Pharmacovigilance and complaints teams may want to review any reports of reduced efficacy with topical lidocaine products against this recall.
  • The recall is ongoing and nationwide in the US, so distributors and pharmacies should monitor the FDA entry for updates.

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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