Sun Pharmaceutical Recalled Lidocaine and Nystatin
The pharmaceutical company initiated a voluntary recall after products failed to meet necessary stability standards.
Updated on Sept. 26, 2026 in Healthcare
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Sun Pharmaceutical Industries initiated a voluntary recall of Lidocaine ointment and Nystatin cream in the United States on August 31, 2026. The action followed failed stability and assay testing procedures for both medical products.
Why it matters
Recalls ensure that healthcare providers and patients avoid using products that did not meet quality specifications. The FDA move to classify the Lidocaine recall as Class II reflects potential, though temporary or reversible, health risks.
The recall involves 65,328 jars of Lidocaine ointment that failed to meet assay specifications during 24-month stability testing.
The players
Sun Pharmaceutical Industries
This multinational pharmaceutical company manufactures and markets a wide range of generic and specialty medications globally.
Food and Drug Administration
The federal agency is responsible for protecting public health by ensuring the safety and efficacy of medical products in the United States.
The details
The Lidocaine ointment was manufactured at a facility in Brampton, Canada, while the Nystatin cream was produced in Haifa Bay, Israel. Both products were pulled from the market after internal testing revealed they failed to comply with required stability standards.
Timeline
August 31, 2026: Sun Pharmaceutical Industries initiated the voluntary Lidocaine recall.
Market Landscape
This recall aligns with the FDA Class II recall classification, which categorizes medical products that may cause temporary or reversible adverse health consequences. By pulling these items, Sun Pharmaceutical Industries maintains regulatory compliance within the broader pharmaceutical safety environment.
Patients currently using Lidocaine ointment or Nystatin cream should consult their healthcare providers to verify if their specific product batches are part of this recall. Retailers and pharmacies are expected to remove these affected units from their inventory to ensure consumer safety.
The takeaway
When medical products fail stability testing, manufacturers act to remove them to prevent potential adverse patient reactions. Patients should always check with their pharmacist or physician if they receive notice of a medication recall.
Further reading
For more on industry quality standards, visit the Healthcare section.
Source note: This article includes information reported by ETPharma.
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