CLASS II Drug recall · Reported 4 Sep 2024 · FDA Enforcement Report
Cefixime for Oral Suspension USP, 100 mg recalled
Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension USP, 100 mg, distributed nationwide in the US. The recall was initiated on 21 Aug 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0648-2024
- FDA event ID
- 95193
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Cefixime
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2024
- FDA classified
- 26 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 21 Aug 2024 | Recall initiated by company | |
| 26 Aug 2024 | Classified by FDA | +5 days |
| 4 Sep 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA nationwide.
Questions about this recall
Is Cefixime for Oral Suspension USP, 100 mg recalled?
Yes. Lupin Pharmaceuticals recalled Cefixime for Oral Suspension USP, 100 mg on 21 Aug 2024. The recall is Class II and its status is Terminated. Recall number D-0648-2024.
Why was it recalled?
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Which lots are affected?
Lot #: F201517, Exp 11/30/2024
Where was it sold?
USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
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Other Cefixime recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefixime for Oral Suspension USP 200 mg/ Pack size) recalledCefixime | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cefixime for Oral Suspension 100mg recalled by Lupin PharmaceuticalsCefixime | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefixime Capsules, 400 mg recalled by Ascend LaboratoriesCefixime | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefixime Capsules 400 mg recalled by Ascend LaboratoriesCefixime | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefixime for Oral Suspension USP 100 mg/ HDPE recalledCefixime | Lupin Pharmaceuticals | Potency & Assay | Nationwide |