The FDA enforcement report lists a Class II recall, dated 23 September 2026, of Lidocaine Ointment USP 5% in 50 g jars manufactured by Taro Pharmaceuticals, with Sun Pharma/Taro named as the firm. The reason is failed content uniformity: the drug content was out of specification at the 24-month stability check. The recall was listed as ongoing.
Class II means the product may cause temporary or reversible health effects, or that serious harm is unlikely. The issue is the amount of lidocaine in this product, not a new safety finding about lidocaine. The notice concerns the US market; whether the affected lots reached India is not stated.
- Check whether your pharmacy stocks the named 5% lidocaine ointment product.
- If so, follow the supplier's recall instructions and quarantine affected stock.
- Expect inconsistent effect from affected product, since the drug content may be off specification.
- No change to lidocaine use in general follows from this notice.
Why it matters
Topical lidocaine is used widely before procedures, and an off-specification product may not numb as expected.
Don't overread it
A content-uniformity recall concerns one manufacturer's product; it is not evidence that lidocaine ointment is unsafe.
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