Three top Indian pharma giants Sun Pharma, Lupin, and Dr. Reddy’s are recalling drug batches from the US market. The recalls were triggered by quality concerns raised by the US FDA. The affected medicines include ADHD drugs, blood pressure tablets, and gastric treatments. Issues like dissolution failure and product mix-up have been reported. All three recalls fall under the “Class II” category, which means the risk to patients is moderate and reversible. For Indian pharma exporters, this is another reminder of how important strict quality checks are in global markets.

Key Highlights

Sun Pharma recall due to failed dissolution specs

• Sun Pharmaceutical Industries is recalling 5,448 bottles of Lisdexamfetamine Dimesylate (60 mg) in the US.

• The ADHD treatment drug failed dissolution specification tests.

• The Class II recall was initiated on June 16, 2025.

Lupin recall triggered by product mix-up

• Lupin is recalling 58,968 bottles of Lisinopril and Hydrochlorothiazide tablets (20mg/12.5mg).

• The recall was prompted by a customer complaint about a foreign tablet Atazanavir and Ritonavir found in a sealed bottle.

• Manufactured in Nagpur, the Class II recall began on June 20, 2025.

Dr Reddy’s recall due to foreign tablets

• Dr. Reddy’s Laboratories is recalling 1,476 bottles of Omeprazole delayed-release capsules.

• A foreign tablet Divalproex Sodium was discovered in one of the bottles.

• The recall began on June 30, 2025, involving products made at its Bachupally facility.

While these recalls may not pose immediate danger to public health, they highlight ongoing challenges in quality assurance for Indian drug manufacturers operating in regulated markets like the US. Ensuring stringent checks, traceability, and packaging accuracy will be essential as Indian pharma companies scale globally.