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Drug FDA Class II Ongoing Foreign material

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.

Graviti Pharmaceuticals Private Limited Published Jan 28, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Graviti Pharmaceuticals Private Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Foreign Substance

Hazards

Foreign Substance · primary

Affected products (1)

Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.

FUROSEMIDE · 4212 bottles

NDC: 64980-562, 64980-563, 64980-564, 64980-562-01, 64980-562-10, 64980-563-01, 64980-563-10, 64980-564-01, 64980-564-50
Lot codes: FUB125042G
Code info: Lot# FUB125042G; Exp. 05/13/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 10, 2026
  2. Published
    Jan 28, 2026
Recall number
D-0293-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.