Lupin and Dr Reddy’s Recall Drugs in the US Over Quality Issues

Pharmaceutical company Lupin is recalling over 600,000 bottles of its high blood pressure medication, Ramipril, in the United States. The recall is due to deviations from current good manufacturing practices (CGMP), as reported by the US Food and Drug Administration (USFDA).

Details of the Lupin Recall

Lupin Pharmaceuticals Inc., a US-based subsidiary of Mumbai-headquartered Lupin, is recalling a total of 616,506 bottles of Ramipril capsules, including:

• 112,770 bottles of 2.5 mg capsules
• 146,322 bottles of 5 mg capsules
• 357,414 bottles of 10 mg capsules

The affected drugs were manufactured at Lupin’s facility in Goa, India. The recall is classified as a Class II voluntary recall, which is issued when a product defect may cause temporary or reversible health issues with a low risk of serious harm. The recall, initiated on October 23, 2024, was due to the active pharmaceutical ingredient being sourced from an unapproved vendor, according to the USFDA.

Dr Reddy’s Laboratories Also Issues a Recall

Dr Reddy’s Laboratories, another major drug manufacturer, is recalling 3,416 bottles of its ibuprofen 600 mg tablets in the US. The product was made in India and recalled under a Class III category due to failure to meet tablet or capsule specifications.

The USFDA describes a Class III recall as a situation where the defective product is unlikely to cause any adverse health effects. Dr Reddy’s recall was initiated on October 29, 2024.

Significance of These Recalls

Both recalls highlight the importance of strict adherence to manufacturing standards and regulatory compliance in the pharmaceutical industry, as even minor deviations can result in significant corrective actions to ensure patient safety.

Lupin share price is trading at ₹2,080.50, showing a decline of ₹26.65 or 1.26% as of 9:47 AM on November 26. The stock opened at ₹2,107.05, reached a high of ₹2,113.15, and a low of ₹2,080.00 during the session.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.