New Delhi, September 2026: Sun Pharma recall 2026 includes two topical prescription medicines in the United States—Lidocaine Ointment and Nystatin Cream—following quality issues identified during testing. According to the latest US FDA enforcement information reported by ETPharma, 65,328 jars of Lidocaine Ointment were recalled after failing assay specifications during long-term stability testing, while an undisclosed quantity of Nystatin Cream was recalled following a stability-testing failure.
Quick Summary
Sun Pharma has initiated voluntary recalls of Lidocaine Ointment and Nystatin Cream in the US due to quality-related testing issues. The Lidocaine recall involves 65,328 jars and was classified as a Class II recall. The affected products were manufactured at Taro Pharmaceuticals facilities in Canada and Israel.
Sun Pharma Recall 2026: Key Details
| Product | Recall Issue | Quantity | Manufacturing Site |
|---|---|---|---|
| Lidocaine Ointment | Failed assay specifications during long-term stability testing | 65,328 jars | Brampton, Canada |
| Nystatin Cream | Failed stability testing | Undisclosed | Haifa Bay, Israel |
The information was reported from the US FDA’s enforcement information and covered by ETPharma.
Lidocaine Ointment Recall
Sun Pharma recalled 65,328 jars of Lidocaine Ointment in the United States after the affected product failed to meet its assay specifications during long-term stability testing at 24 months.
The affected batch was manufactured at the Taro Pharmaceuticals facility in Brampton, Canada. Taro Pharmaceuticals is a wholly owned subsidiary of Sun Pharma.
The voluntary recall was initiated on August 31, 2026, and was classified by the US FDA as a Class II recall.
What Is Lidocaine?
Lidocaine is a local anesthetic that temporarily reduces sensation in a specific area by blocking nerve signals associated with pain.
Topical lidocaine preparations are used for local pain relief and numbing.
Nystatin Cream Recall
Sun Pharma also recalled an undisclosed quantity of Nystatin Cream in the United States following a failure in stability testing.
The affected batch was manufactured at Taro Pharmaceuticals’ Haifa Bay facility in Israel.
What Is Nystatin?
Nystatin is an antifungal medication used to treat infections caused by Candida species.
The recalled Nystatin Cream is a topical prescription medicine in the US.
Why Was Lidocaine Ointment Recalled?
The Lidocaine Ointment batch was recalled because it failed to meet assay specifications during long-term stability testing at 24 months.
What Does Assay Testing Mean?
In pharmaceutical quality control, an assay test is used to determine the amount or concentration of the active pharmaceutical ingredient in a medicine.
For pharmacy students, assay testing is an important part of pharmaceutical quality control because it helps verify that a product continues to meet its specified requirements.
Why Was Nystatin Cream Recalled?
The Nystatin Cream recall followed a failure in stability testing. The available report does not specify the exact stability parameter that failed.
Exact failed stability parameter: Not mentioned in the available report.
What Is a Class II Drug Recall?
The Lidocaine Ointment recall was classified as Class II.
According to the FDA’s recall classification framework, a Class II recall involves a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is considered remote.
The FDA explains that a drug recall is a voluntary action taken by a company to remove a defective drug from the market or warn consumers about a potential risk.
Manufacturing Sites Involved
| Medicine | Manufacturer / Facility | Country |
|---|---|---|
| Lidocaine Ointment | Taro Pharmaceuticals, Brampton facility | Canada |
| Nystatin Cream | Taro Pharmaceuticals, Haifa Bay facility | Israel |
Both manufacturing facilities are associated with Taro Pharmaceuticals, a wholly owned subsidiary of Sun Pharma, according to the report.
Important Dates
| Event | Date |
|---|---|
| Lidocaine Ointment recall initiated | August 31, 2026 |
| Report published by ETPharma | September 26, 2026 |
| Nystatin Cream recall initiation date | Not mentioned in the available report |
Why Is Stability Testing Important in Pharmacy?
Stability testing helps determine whether a pharmaceutical product continues to meet established quality specifications throughout its intended shelf life.
It can evaluate factors such as:
- Active ingredient content
- Physical characteristics
- Chemical stability
- Microbiological quality, where applicable
- Product performance
- Storage-related changes
The exact tests performed depend on the dosage form and applicable product specifications.
Why Should Pharmacy Students Know About This Recall?
This recall is relevant to B.Pharm, D.Pharm, M.Pharm and pharmacy exam aspirants because it connects real-world pharmaceutical manufacturing with important concepts such as:
- Pharmaceutical quality control
- Assay testing
- Stability testing
- Drug recalls
- FDA regulatory action
- Good Manufacturing Practices
- Quality assurance
These topics are also useful for students preparing for GPAT, NIPER JEE, Drug Inspector and Pharmacist examinations.
Impact on Pharmaceutical Quality
The Sun Pharma recalls highlight why pharmaceutical manufacturers conduct quality testing throughout a product’s lifecycle.
A medicine must continue to meet its specified quality requirements during its shelf life. Stability studies and quality-control testing can help identify products that no longer meet applicable specifications.
Important Links
- US FDA Drug Recall Information: The FDA provides information about drug recalls and its recall classification framework.
- Source Report – ETPharma: The recall details were reported by ETPharma on September 26, 2026.
FAQs
1. Which medicines did Sun Pharma recall in the US in 2026?
Sun Pharma recalled Lidocaine Ointment and Nystatin Cream in the US following quality-related testing issues.
2. Why was Lidocaine Ointment recalled?
The affected Lidocaine Ointment batch failed to meet assay specifications during long-term stability testing at 24 months.
3. How many Lidocaine Ointment jars were recalled?
The recall involved 65,328 jars of Lidocaine Ointment.
4. What was the reason for the Nystatin Cream recall?
Nystatin Cream was recalled following a failure in stability testing. The specific failed stability parameter was not mentioned in the available report.
5. Where was the recalled Lidocaine Ointment manufactured?
The affected Lidocaine Ointment batch was manufactured at Taro Pharmaceuticals’ Brampton facility in Canada.
6. Where was the recalled Nystatin Cream manufactured?
The affected Nystatin Cream batch was manufactured at Taro Pharmaceuticals’ Haifa Bay facility in Israel.
7. What is a Class II recall?
A Class II recall involves a product that may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse health consequences considered remote.
8. What can pharmacy students learn from this recall?
The recall provides a practical example of assay testing, stability testing, pharmaceutical quality control and regulatory drug recalls.
Conclusion
The Sun Pharma recall 2026 involving Lidocaine Ointment and Nystatin Cream highlights the importance of pharmaceutical quality testing and stability studies. The Lidocaine recall involved 65,328 jars after the product failed assay specifications during long-term stability testing, while the Nystatin Cream recall followed a stability-testing failure.
For pharmacy students and professionals, the case provides a useful real-world example of how assay testing, stability testing, quality control and regulatory recall procedures contribute to maintaining pharmaceutical product quality.
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