Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size) recall
FDA recall D-0559-2024 · initiated May 30, 2024
Lupin Pharmaceuticals Inc. recalled Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size) in May 2024 — an FDA Class II recall (D-0559-2024) because Failed Content Uniformity Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Content Uniformity Specifications
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: 3,552 bottles
Details
- Product
- Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- May 30, 2024
- FDA report date
- Jun 26, 2024
Frequently asked
- Was Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size) recalled?
- Lupin Pharmaceuticals Inc. recalled Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size) in May 2024 — an FDA Class II recall (D-0559-2024) because Failed Content Uniformity Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size) recalled?
- Per the FDA enforcement record, the reason for recall D-0559-2024 was: Failed Content Uniformity Specifications
- Is a recalled Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size) 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 200 mg/5 mL (50 mL Pack size) are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot F201519, Expiry: November 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-0559-2024.