Cefixime for Oral Suspension USP recall
FDA recall D-0648-2024 · initiated Aug 21, 2024
Lupin Pharmaceuticals Inc. recalled Cefixime for Oral Suspension USP in Aug 2024 — an FDA Class II recall (D-0648-2024) because Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 4554 bottles
Details
- Product
- Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Aug 21, 2024
- FDA report date
- Sep 4, 2024
Frequently asked
- Was Cefixime for Oral Suspension USP recalled?
- Lupin Pharmaceuticals Inc. recalled Cefixime for Oral Suspension USP in Aug 2024 — an FDA Class II recall (D-0648-2024) because Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cefixime for Oral Suspension USP recalled?
- Per the FDA enforcement record, the reason for recall D-0648-2024 was: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
- Is a recalled Cefixime for Oral Suspension USP 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 Cefixime for Oral Suspension USP are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot #: F201517, Exp 11/30/2024. 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-0648-2024.