Taro Pharmaceutical, a subsidiary of Sun Pharmaceutical, has initiated a recall of over 17,000 units of an antifungal shampoo in the United States after manufacturing issues were flagged by the US Food and Drug Administration (USFDA).
According to the USFDA’s latest Enforcement Report, Taro is recalling 17,664 units of Ciclopirox Shampoo in the US after manufacturing-related issues were identified. The product is used to treat seborrheic dermatitis, a skin condition marked by dryness, flaking and itching.
The US regulator said the affected batch failed to meet impurity or degradation specifications. A nationwide voluntary recall was initiated on December 9 under the Class II category.
According to the USFDA, a Class II recall is issued when the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or when the likelihood of serious adverse outcomes is minimal.
Sun Pharma acquired Israel-based Taro last year in a deal valued at about $347.7 million, taking the company private and making it a wholly owned subsidiary. Sun Pharma has been Taro’s majority shareholder since 2010.
Sun Pharma Q2 performance
Sun Pharmaceutical Industries, India’s largest formulation player by market share and a leading exporter to the US market, reported an 8.93 per cent rise in revenue to ₹14,478 crore in the second quarter of FY26. Net profit rose 2.56 per cent year-on-year to ₹3,118 crore.
However, formulation sales in the US declined 4.1 per cent to $496 million. The company said weakness in its generics business was offset by growth in innovative medicines. The US accounted for about 30.1 per cent of consolidated sales, with first-half revenue at $968 million.
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