CLASS II Drug recall · Reported 26 Jun 2024 · FDA Enforcement Report
Cefixime for Oral Suspension USP 200 mg/ Pack size) recalled
Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension USP 200 mg/ Pack size), Powder for oral suspension, distributed nationwide in the US. The recall was initiated on 30 May 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-0559-2024
- FDA event ID
- 94723
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Cefixime
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 May 2024
- FDA classified
- 18 Jun 2024
- Reported
- 26 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 30 May 2024 | Recall initiated by company | |
| 18 Jun 2024 | Classified by FDA | +19 days |
| 26 Jun 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications
Which lots are affected?
Lot F201519, Expiry: November 2024
Where was it sold?
Nationwide in the US
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 26 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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Other Cefixime recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefixime for Oral Suspension USP, 100 mg recalledCefixime | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefixime for Oral Suspension 100mg recalled by Lupin PharmaceuticalsCefixime | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefixime 400 mg capsule, packaged in a) 2-count bottle recalled | RemedyRepack | Potency & Assay | MI, PA |
| 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 |