FDA recall: lidocaine 5% ointment jars for uneven content

The FDA lists an ongoing Class II recall, dated 14 October 2026, of lidocaine ointment USP 5% in 50 g jars, manufactured by Taro Pharmaceuticals U.S.A. and distributed by Preferred Pharmaceuticals. The stated reason is failed content uniformity specifications, meaning the amount of lidocaine may not be evenly distributed through the product.

A Class II recall covers products where use may cause temporary or medically reversible effects, with a remote probability of serious harm. In practice, uneven content could mean less effective topical anaesthesia or, in some portions, a higher local dose than expected.

This is a US recall of specific lots from one distributor. Whether any affected stock reached other markets is not stated.

• Check any lidocaine 5% ointment from this distributor against the FDA recall notice and quarantine affected lots.
• Uneven drug content may give unreliable topical anaesthesia from the affected jars.
• Keep total lidocaine doses within recommended limits when topical and other routes are combined.
• Other lidocaine formulations and manufacturers are not covered by this notice.

Why it matters

A topical anaesthetic with uneven content may fail at the procedure or deliver more drug than intended.

Don't overread it

This is a manufacturing quality recall, not a new safety finding about lidocaine.

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