Tablets Recalled for Foreign Substance

The presence of a foreign substance has prompted Dr Reddy’s Laboratories Inc. to recall allopurinol tablets distributed in 3 states, according to the July 10, 2024, US Food and Drug Administration (FDA) Enforcement Report. The report provides no information about the foreign substance found in the tablets.

The recall affects allopurinol tablets, 300 mg, in 100-count bottles (NDC 55111-730-01) from lot L2300594 (no expiration date was provided). The tablets were manufactured by Dr Reddy’s Laboratories, Shreveport, Louisiana, and were distributed in Illinois, Mississippi, and Ohio.

Dr Reddy’s Laboratories voluntarily initiated the recall on June 7, 2024. On July 3, 2024, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Allopurinol is a prescription uric acid reducer with indications for patients with gout, patients receiving cancer therapy that causes elevations of serum and urinary uric acid levels, and patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients.