CLASS II Drug recall · Reported 5 Jun 2019 · FDA Enforcement Report
Cefdinir for Oral Suspension USP, 250mg/, Powder for oral suspension recalled
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension USP, 250mg/, Powder for oral suspension, distributed nationwide in the US. The recall was initiated on 23 May 2019 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-1320-2019
- FDA event ID
- 82939
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Cefdinir
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2019
- FDA classified
- 30 May 2019
- Reported
- 5 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Antibiotics
Timeline
| 23 May 2019 | Recall initiated by company | |
| 30 May 2019 | Classified by FDA | +7 days |
| 5 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Which lots are affected?
Lot # F802335, exp. date November 2020
Where was it sold?
Distributed Nationwide in the USA
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 Cefdinir recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefdinir for Oral Suspension USP, 250 mg recalledCefdinir | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Cefdinir for Oral Suspension USP 125 mg/ when reconstituted) recalledCefdinir | Lupin Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Cefdinir for Oral Suspension USP 250 mg/ when reconstituted) recalledCefdinir | Lupin Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Cefdinir for Oral Suspension USP, 250 mg recalledCefdinir | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Cefdinir for Oral Suspension USP, 125 mg recalledCefdinir | Lupin Pharmaceuticals | Packaging Defects | Nationwide |