Two major Indian pharmaceutical manufacturers, Sun Pharmaceutical Industries and Macleods Pharmaceuticals, have recalled specific drug batches from the United States market following quality-related concerns flagged by the US Food and Drug Administration (FDA).
Macleods Pharmaceuticals Recalls Famciclovir Tablets
Macleods has voluntarily issued a Class III recall for 9,888 bottles of Famciclovir tablets (500 mg) from the US market. According to an FDA enforcement report released on July 16, 2025, the recall decision was prompted by the discovery of a small, black hair-like particle stuck to a tablet inside a sealed bottle—a clear no-go under manufacturing safety standards.
The recalled batches were manufactured at Macleods Daman facility in India and were distributed by Macleods Pharma USA Inc. The action was officially initiated on June 11, 2025.
What Is a Class III Recall?
A Class III recall indicates a violation of FDA regulations, but the use of or exposure to the product is not likely to cause adverse health consequences. This makes it the least severe category among FDA recalls. Nevertheless, it raises concerns about adherence to Good Manufacturing Practices (GMP).
About Famciclovir
Famciclovir is an antiviral medication widely used to treat infections like:
- Herpes zoster (shingles)
- Recurrent genital herpes
- Herpes infections in immunocompromised patients, including those with HIV
It’s an essential drug for both acute and chronic antiviral treatments, making any quality issues particularly sensitive for both patients and regulators.
Sun Pharma Also Pulls Product from the US Market
In a significant compliance action, Sun Pharmaceutical Industries has initiated Class II recalls from the US market, covering different product Lisdexamfetamine Dimesylate Capsules (60 mg) due to quality specification failures.
Lisdexamfetamine Dimesylate Capsules (60 mg), produced at the OHM Laboratories facility, have been recalled. A total of 5,448 bottles, distributed by Sun Pharmaceuticals, Inc., were affected. The recall is initiated on June 16, 2025. The product did not meet dissolution specifications during the long-term stability testing.
Regulatory Scrutiny Tightens on Indian Pharma
These recalls come at a time when Indian pharmaceutical manufacturers are facing increased scrutiny from international regulators, particularly the FDA and EMA. Inspections have become more frequent, with an emphasis on contamination risks, product integrity, and data reliability.
For Indian drug makers heavily reliant on the US market, such recalls—while voluntary—can affect brand reputation, business continuity, and regulatory trust.
What It Means for the Pharma Industry
- Quality control lapses, even if minor, can lead to widespread market recalls and legal obligations abroad.
- The US drug market’s regulatory landscape is unforgiving, requiring absolute adherence to CGMP norms.
- Indian manufacturers must invest in automated quality assurance systems and enhanced workforce training to maintain global competitiveness.
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