According to the USFDA, Dr. Reddy's Laboratories and Lupin Pharmaceuticals, two of India's largest pharmaceutical firms, recalled a product from the US on account of labeling and manufacturing problems.
Dr. Reddy's Laboratories, based in Hyderabad, is recalling 4,010 injection bags of a commonly used antiepileptic because of an incorrect labeling mismatch. The drug in question is Levetiracetam in Sodium Chloride Injection (1,000 mg/100 mL) manufactured by its American subsidiary at Princeton, said the USFDA.
USFDA said: "The infusion bag is incorrectly labelled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL."
The issue comprises two different labels: one on the infusion bag and the other on the overwrap. While the overwrap correctly labels the contents as levetiracetam in 0.75% sodium chloride, 1,000 mg/100 mL, the bag carries a label for levetiracetam in 0.82% sodium chloride, 500 mg/100 mL. This discrepancy is capable of causing confusion in dosing or misadministration.
This was rated as a Class I recall by the highest level of recall. This is for products whose use or exposure may cause serious adverse health consequences or death. The recall was initiated nationwide on March 13, 2025.
Lupin withdrew the antidepressant from the market due to impurities
In another action, Lupin Pharmaceuticals Ltd, based in Mumbai, recalled an obsessive-compulsive disorder (OCD) treatment. According to the FDA report, its U.S. subsidiary based in Naples is recalling 2,724 bottles of clomipramine hydrochloride capsules (25 mg strength).
Class II recall is defined as when a product may cause temporary or clinically reversible health effects, or where the probability of serious adverse health effects is remote. Lupin initiated the recall on April 18, 2025.
Why these recalls matter
Pharmaceutical recalls, especially Class I and Class II ones, highlight how quality control and regulatory compliance impact the drug manufacturing and distribution process. In the case of Dr. Reddy's Laboratories, mislabeling can result in user confusion, incorrect dosing, and grave health consequences. Purity issues concerning Lupin's products are yet another example where safety and efficacy are challenged.
These recalls are still being followed by the USFDA, which is stressing vigilance among healthcare providers and patients and cautions them to take care while using or prescribing these drugs.
(Input from various media sources)
(Rehash/Muhammad Faisal Arshad/MSM)
