The FDA enforcement record lists a Class II recall of lidocaine ointment USP 5% in 50 g jars, manufactured by Taro Pharmaceuticals U.S.A., with Preferred Pharmaceuticals as the recalling firm. The reason given is failed content uniformity specifications, meaning the drug may not be evenly distributed through the product. The recall was listed as ongoing on 14 October.
Class II means use may cause temporary or reversible effects, or that serious harm is unlikely. Uneven content could mean less effective analgesia or, in a large application, more systemic exposure than expected.
This is a US recall of named lots. Whether these lots are supplied in India is not stated in the record.
- The recall covers 5% lidocaine ointment in 50 g jars from the named firms.
- The reason is failed content uniformity.
- It is Class II: serious harm is judged unlikely.
- Check stock against the recall notice if you supply this product.
Why it matters
Uneven content in a topical anaesthetic can make the dose a patient absorbs unpredictable.
Don't overread it
This is a manufacturing-quality recall, not a safety finding about lidocaine.
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