Cefdinir for Oral Suspension USP recall
FDA recall D-0518-2024 · initiated May 8, 2024
Lupin Pharmaceuticals Inc. recalled Cefdinir for Oral Suspension USP in May 2024 — an FDA Class II recall (D-0518-2024) because Defective container: lack of seal integrity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container: lack of seal integrity.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
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: 51,006 bottles
Details
- Product
- Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 8, 2024
- FDA report date
- Jun 5, 2024
Frequently asked
- Was Cefdinir for Oral Suspension USP recalled?
- Lupin Pharmaceuticals Inc. recalled Cefdinir for Oral Suspension USP in May 2024 — an FDA Class II recall (D-0518-2024) because Defective container: lack of seal integrity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cefdinir for Oral Suspension USP recalled?
- Per the FDA enforcement record, the reason for recall D-0518-2024 was: Defective container: lack of seal integrity.
- Is a recalled Cefdinir 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 Cefdinir for Oral Suspension USP are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #F305184, F305185, F305186, Exp 7/31/ 2025. 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-0518-2024.