Why Did Sun Pharma’s Taro Recall Over 17,000 Units of Antifungal Shampoo in the US?
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Synopsis
In a significant health safety move, Taro Pharmaceutical Industries, a subsidiary of Sun Pharma, has launched a recall of over 17,000 units of its antifungal shampoo. This action follows concerns raised by the USFDA regarding manufacturing defects. Discover the implications of this recall on the market and consumer safety.
Key Takeaways
- Taro Pharmaceutical recalls over 17,000 units of shampoo.
- Recall due to manufacturing defects as per USFDA.
- Ciclopirox Shampoo treats seborrheic dermatitis.
- Class II recall indicates minimal serious health risks.
- Sun Pharma acquired Taro in a transaction valued at $347.73 million.
New Delhi, Dec 25 (NationPress) - The US division of Sun Pharma, Taro Pharmaceutical Industries, has initiated a recall of over 17,000 units of an antifungal shampoo due to manufacturing defects, according to the U.S. Food and Drug Administration (USFDA).
The Ciclopirox Shampoo, which is used as a treatment for seborrheic dermatitis—a condition characterized by dry, flaky, and itchy skin—is being pulled from the market due to "failed impurity/degradation specifications," as reported in the latest Enforcement Report by the USFDA.
This nationwide recall, categorized as a Class II action, includes 17,664 units of Ciclopirox Shampoo and was officially launched by the company on December 9.
The USFDA defines a Class II recall as a product that may lead to temporary or medically reversible health issues, with a minimal chance of serious adverse health outcomes.
Taro is a private entity fully owned by Sun Pharma. The company, based in Israel, was acquired by Sun Pharma in a transaction valued at approximately $347.73 million last year.
Since 2010, Sun Pharma has held a majority stake in Taro.
Focused primarily on dermatological products, Taro manufactures a variety of prescription and over-the-counter items.
Indian pharmaceutical firms contribute significantly to the U.S. drug supply, with nearly 40% of all prescriptions in the U.S. filled by Indian companies in 2022.
Sun Pharmaceutical Industries stands as India’s largest player in the formulation market by market share and is a leading exporter to the U.S., reporting revenue of Rs 14,478 crore in the second quarter of FY26.
Despite a 2.56% year-on-year increase in net profit to Rs 3,118 crore, Taro reported a 4.1% decline in formulation sales in the U.S., totaling $496 million.
This decline in the generics sector was balanced by growth in innovative medicine offerings, as noted by the company.
Point of View
This recall by Taro Pharmaceutical is a reminder of the stringent regulatory environment governing pharmaceuticals in the U.S. Consumer safety must always come first, and such actions reflect the ongoing commitment to public health. As we analyze this incident, it emphasizes the need for rigorous quality controls in pharmaceutical manufacturing.
NationPress
25/12/2025
Frequently Asked Questions
What is the reason for Taro's shampoo recall?
The recall is due to manufacturing issues related to failed impurity and degradation specifications.
How many units of the shampoo are being recalled?
A total of 17,664 units of Ciclopirox Shampoo are being recalled.
What is Ciclopirox Shampoo used for?
Ciclopirox Shampoo is an antifungal medication used to treat seborrheic dermatitis.
What does a Class II recall mean?
A Class II recall indicates that the product may cause temporary or medically reversible health consequences.
Who owns Taro Pharmaceutical Industries?
Taro is a wholly-owned subsidiary of Sun Pharmaceutical Industries.
