New Delhi, January 26 (IANS). Indian pharmaceutical companies Sun Pharmaceutical Industries and Cipla have recalled some of their medicines from the US market due to manufacturing problems. This information has come to light in the latest report of the US Food and Drug Administration (USFDA).
In an enforcement report, the US health regulator said that the US-based unit of Mumbai-headquartered Sun Pharma is recalling thousands of bottles of a generic drug. This medicine is used in the treatment of problems like dandruff and skin inflammation and itching.
Sun Pharmaceutical Industries Inc., based in Princeton, New Jersey, has recalled 24,624 bottles of fluocinolone acetonide topical solution. Investigation found that this medicine was not meeting the prescribed standards of impurity and quality.
The company initiated a nationwide Class III recall in the US on December 30, 2025. According to the USFDA, Class III recalls are made in cases where the risk of harm to health from the use of the drug is very low.
USFDA also informed that Sun Pharma has also recalled some batches of the drug named Clindamycin Phosphate USP. This medicine is used in the treatment of acne.
The drug was recalled on November 26, 2025, after testing found impurity levels and quantity outside the prescribed limits. This has also been placed in a Class III recall.
On the other hand, USFDA said that Cipla’s US-based unit has also recalled more than 15,000 injection syringes from the US market.
Cipla USA Inc. is headquartered in Warren, New Jersey. It has recalled 15,221 pre-filled syringes of lanreotide injection. Particles have been found in these syringes.
Cipla initiated this recall on January 2, 2026 under Class II recall. According to the USFDA, a Class II recall is made when use of the drug may cause temporary or reversible health effects, although the likelihood of serious harm remains low.
America is the world’s largest pharmaceutical market. Therefore, it is considered very important for the pharmaceutical companies working there to follow the rules and maintain the quality of the medicines.
–IANS
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