Sun Pharma and Cipla Face US Product Recalls Due to Manufacturing Issues
Sun Pharma and Cipla are facing US product recalls due to manufacturing quality issues. Sun Pharma is recalling over 26,000 bottles of generic medications for failed impurity specifications, while Cipla recalls 15,221 syringes due to particulate matter. The recalls are classified as Class II and Class III by the US FDA, with both companies experiencing recent stock price declines.
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Two prominent Indian pharmaceutical companies are facing regulatory challenges in the United States as the US Food and Drug Administration has announced product recalls for both Sun Pharma and Cipla due to manufacturing-related quality issues.
Sun Pharma Recall Details
Sun Pharmaceutical Industries Inc., the Princeton-based US arm of the Mumbai-headquartered company, has initiated recalls for multiple generic medications. The company is recalling 24,624 bottles of Fluocinolone Acetonide Solution Topical Solution, a medication used for treating dandruff and skin conditions involving inflammation and itching.
| Product Details: | Information |
|---|---|
| Product Name: | Fluocinolone Acetonide Solution Topical Solution |
| Bottles Recalled: | 24,624 |
| Recall Date: | December 30, 2025 |
| Reason: | Failed Impurities/Degradation Specifications |
| Classification: | Class III |
Additionally, Sun Pharma initiated a Class III recall of Clindamycin Phosphate USP on November 26, 2025. This acne vulgaris treatment medication was recalled due to "Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay."
Cipla's US Market Recall
Cipla's Warren-based US operations are recalling 15,221 syringes of Lanreotide Injection in the American market. The recall affects the 120 mg/0.5 mL dosage in 0.5 mL pre-filled syringes and was initiated on January 2 due to the presence of particulate matter.
| Cipla Recall Summary: | Details |
|---|---|
| Product: | Lanreotide Injection |
| Dosage: | 120 mg/0.5 mL |
| Units Recalled: | 15,221 syringes |
| Recall Date: | January 2 |
| Issue: | Presence of particulate matter |
| Classification: | Class II |
Understanding FDA Recall Classifications
The US FDA categorizes recalls based on potential health risks. A Class II recall is initiated when product use could lead to temporary health consequences or when the possibility of serious adverse health outcomes is limited. In contrast, a Class III recall occurs in situations where product use is not likely to cause adverse health consequences.
Market Impact
Both pharmaceutical companies have experienced recent stock price declines. Cipla shares have fallen close to 12% in the past month, bringing the share price to ₹1,315.00 per piece. Sun Pharma shares have declined close to 5% during the same period, falling to ₹1,631.00 per share.
These recalls highlight ongoing quality control challenges that Indian pharmaceutical companies face in maintaining compliance with stringent US regulatory standards while operating in one of their key export markets.
Historical Stock Returns for Cipla
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.72% | -6.58% | -13.01% | -11.40% | -10.04% | +56.01% |
