Taro Recalls Lidocaine Ointment for Failed Content Uniformity Specifications
Taro Pharmaceuticals is recalling Lidocaine Ointment 5% due to failed content uniformity specifications during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the defect is a stability specification failure rather than a high-risk pathogen or structural defect.
Plain-English summary
Taro Pharmaceuticals is recalling Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar. The recall affects 65,328 jars of the product, which is distributed nationwide in the USA. The specific lot number is AD48154, with an expiration date of 4/30/2027.
The recall was initiated because the product failed Content Uniformity Specifications. Specifically, the product was out of specification for Assay during analysis at the 24-month long-term stability station at 25°C and 60% relative humidity.
Consumers who have this product should stop using it and return it to the pharmacy where it was purchased or contact Taro Pharmaceuticals for further instructions.
The recalled product
- Product
- LIDOCAINE (LIDOCAINE)
- Brand
- LIDOCAINE
- Manufacturer
- SUN PHARMA /TARO
- Category
- Drug — Topical Anesthetic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AD48154
- Exp: 4/30/2027.
Distribution
Distributed nationwide across the United States.
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