Sun Pharma And Cipla Recall Products In US Market Following USFDA Observations |

Updated: January 26, 2026 17:52

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Indian pharmaceutical majors Sun Pharma and Cipla have initiated product recalls in the United States after the US Food and Drug Administration (USFDA) flagged manufacturing-related issues. Sun Pharma recalled over 26,000 bottles of topical solutions, while Cipla pulled back Lanreotide injections, raising concerns about quality compliance and supply disruptions.

Two of India’s largest drugmakers, Sun Pharmaceutical Industries Ltd and Cipla Ltd, are facing regulatory challenges in the United States after the USFDA reported manufacturing lapses. According to the latest enforcement reports, both companies have initiated precautionary recalls to address safety and compliance concerns.

Key highlights from the announcement include

Sun Pharma’s US arm recalled 24,624 bottles of Fluocinolone Acetonide Topical Solution due to failed impurity and degradation specifications.
The company also recalled certain batches of Clindamycin Phosphate topical medication used for acne treatment.
The recalls were classified as Class III, indicating issues unlikely to cause serious health consequences but requiring corrective action.
Cipla recalled Lanreotide injections, a key product in its US portfolio, following inspectional observations at Pharmathen International S.A., its Greece-based manufacturing partner.
The temporary halt in Lanreotide supply is expected to impact Cipla’s US revenues, as the drug is among its top three products in the market.
Both recalls highlight the importance of stringent quality checks and regulatory compliance in the highly competitive US pharmaceutical sector.

Analysts note that while Class III recalls are generally precautionary and not linked to immediate patient safety risks, they can affect brand reputation and market confidence. For Sun Pharma, the recalls underline the need to strengthen quality assurance processes across its global facilities. Cipla’s case, tied to its supplier’s compliance issues, reflects the risks of dependency on third-party manufacturers.

The USFDA’s enforcement actions serve as a reminder of the strict regulatory environment in the United States, where Indian pharmaceutical companies have a significant presence. Despite these challenges, both Sun Pharma and Cipla remain committed to corrective measures and ensuring uninterrupted supply of safe, effective medicines.

Sources: The Hindu BusinessLine, Economic Times, NewsDrum

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