Furosemide 40 mg Tablets Recalled Due to Foreign Substance Contamination

Key Takeaways

• The US Food and Drug Administration (FDA) announced a voluntary Class II nationwide recall of Furosemide Tablets, USP 40 mg, after the presence of a foreign substance was identified in one lot.
• The affected product was manufactured by Graviti Pharmaceuticals Pvt Ltd and distributed in the US by Rising Pharmaceuticals Inc.
• Pharmacists should identify, quarantine, and follow recall instructions for lot FUB125042G to prevent patient exposure.

The FDA has reported a voluntary nationwide recall of furosemide tablets, USP 40 mg, packaged in 1000-count bottles and labeled Rx only. The product was manufactured by Graviti Pharmaceuticals Pvt Ltd in Telangana, India, and distributed in the US by Rising Pharmaceuticals Inc of East Brunswick, New Jersey. The affected product carries NDC 64980-563-10 and includes 4212 bottles from lot FUB125042G, with an expiration date of May 13, 2027.

The recall has been assigned FDA Recall Number D-0293-2026 and classified as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. According to the FDA Enforcement Report, the recall was firm-initiated and voluntary, with initial notification to consignees conducted via letter. The recall remains ongoing and affects product distributed nationwide across the US.

The reason for the recall is the presence of a foreign substance in the tablets, which raises potential safety and quality concerns for patients and health care providers. No press release has been issued for this recall. The event is tracked under FDA Event ID 98289, with the recall initiated on January 10, 2026, and officially classified by the FDA on January 21, 2026. Pharmacists are advised to review inventory promptly, quarantine affected stock, and follow firm instructions for return or disposal.

Furosemide is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic disease, and renal disease, including nephrotic syndrome, and is also commonly used in the management of hypertension.