The FDA enforcement report dated 23 September 2026 lists an ongoing Class II recall of Lidocaine Ointment USP 5% (spearmint flavour, 50 g jar), manufactured by Taro Pharmaceuticals in Canada, a Sun Pharma company.
The reason given is failed content uniformity, with the assay out of specification at the 24-month stability check. In practice, the drug content may not be consistent through the jar or may have drifted over shelf life. Class II means use may cause temporary or medically reversible harm, or that serious harm is remote.
The recall concerns the US market. Whether this product or batch is supplied in India is not stated.
- Check stock for the named product and remove affected lots if you use it.
- Expect inconsistent topical anaesthesia from affected jars.
- Report any unexpected lack of effect or toxicity to your pharmacy.
Why it matters
Uneven drug content in a topical anaesthetic can mean failed procedural analgesia or, less likely, too much drug.
Don't overread it
A Class II recall for a quality specification is not a finding that lidocaine ointment is unsafe.
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