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India’s leading pharmaceutical companies — Sun Pharma, Lupin, and Dr. Reddy’s Laboratories — have initiated drug recalls in the United States due to quality control concerns, according to the latest report from the US Food and Drug Administration (USFDA).
The recalls involve widely used medications for ADHD, high blood pressure, and acid reflux, raising critical questions about manufacturing practices, regulatory compliance, and global drug safety standards.
These Class II recalls emphasize the importance of stringent quality assurance (QA) protocols and underscore the growing need for regulatory affairs and pharmacovigilance professionals in the pharma industry.
⚠️ Why Are Indian Pharma Giants Recalling Drugs in the US?
Three of India’s leading pharmaceutical companies — Sun Pharma, Lupin, and Dr. Reddy’s Laboratories — have voluntarily recalled several drug batches from the United States market due to manufacturing defects, product mix-ups, and dissolution issues, according to the latest enforcement reports by the US Food and Drug Administration (USFDA).
These actions fall under a Class II recall, which means the defective product may cause temporary or medically reversible health problems, but the probability of serious adverse health consequences is low.
🔍 Overview of the Recalled Drugs
| Company | Drug Name | Reason for Recall | US Recall Date | Manufacturing Site |
|---|---|---|---|---|
| Sun Pharma | Lisdexamfetamine Dimesylate Capsules | Failed Dissolution Specifications | 16 June 2025 | Sun Pharma US |
| Lupin | Lisinopril + Hydrochlorothiazide | Product Mix-Up (Presence of Foreign Tablet) | 20 June 2025 | Nagpur, Maharashtra |
| Dr. Reddy’s Labs | Omeprazole DR Capsules | Foreign Divalproex Tablets Found | 30 June 2025 | Bachupally, Telangana |
💊 Drug-Specific Details
🧠 Sun Pharma’s ADHD Drug Recall
Sun Pharmaceutical Industries, headquartered in Mumbai, recalled 5,448 bottles of Lisdexamfetamine Dimesylate, a generic drug prescribed for Attention Deficit Hyperactivity Disorder (ADHD).
- Issue: Failed dissolution test.
- Impact: Potential risk of reduced drug effectiveness.
- Marketed by: Sun Pharmaceutical Industries Inc., Princeton, USA.
🔗 Related Resource: Understanding ADHD Treatment
🫀 Lupin Recalls Blood Pressure Medication
Lupin Pharmaceuticals Inc., based in Naples, USA, pulled 58,968 bottles of a combination drug — Lisinopril and Hydrochlorothiazide — due to a foreign tablet contamination.
- Wrong Tablet Found: Atazanavir and Ritonavir 300mg/100mg
- Patient Risk: May lead to incorrect treatment outcomes or drug interactions.
🧪 Dr. Reddy’s Recall of Omeprazole
Dr. Reddy’s Laboratories is recalling 1,476 bottles of Omeprazole Delayed-Release Capsules, used for acid reflux and stomach ulcers.
- Issue: Presence of Divalproex Sodium 250mg tablets in Omeprazole bottles.
- Manufactured at: Bachupally facility, India.
📌 What is a Class II Recall?
A Class II recall is issued when a drug defect is unlikely to cause severe health issues but may result in temporary or reversible side effects.
🔗 See official USFDA Recall Classifications
✅ What This Means for Pharma Professionals and Job Seekers
These recalls highlight the importance of quality assurance (QA), regulatory compliance, and pharmacovigilance in the global pharmaceutical industry. It also opens up new job opportunities in USFDA compliance, QA/QC, and regulatory affairs.
📌 Hot Pharma Job Categories in Demand:
- Regulatory Affairs Officer
- QA/QC Analyst
- Pharmacovigilance Associate
- Drug Safety Monitor
- Validation Engineer
Final Words
The recalls by Sun Pharma, Lupin, and Dr. Reddy’s highlight the critical role of cGMP practices, routine quality checks, and global regulatory oversight in pharma manufacturing. As India continues to lead in USFDA-approved facilities, upholding international quality standards remains essential.
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