Furosemide Tablets recall
FDA recall D-0293-2026 · initiated Jan 10, 2026
Graviti Pharmaceuticals Private Limited recalled Furosemide Tablets in Jan 2026 — an FDA Class II recall (D-0293-2026) because Presence of Foreign Substance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Substance
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4212 bottles
Details
- Product
- 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.
- Recalling company
- Graviti Pharmaceuticals Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Jan 10, 2026
- FDA report date
- Jan 28, 2026
Frequently asked
- Was Furosemide Tablets recalled?
- Graviti Pharmaceuticals Private Limited recalled Furosemide Tablets in Jan 2026 — an FDA Class II recall (D-0293-2026) because Presence of Foreign Substance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Furosemide Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0293-2026 was: Presence of Foreign Substance
- Is a recalled Furosemide Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Furosemide Tablets are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot# FUB125042G; Exp. 05/13/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0293-2026.