CLASS II Drug recall · Reported 16 Jan 2019 · FDA Enforcement Report
Cefdinir for Oral Suspension USP, 125mg recalled
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension USP, 125mg, distributed nationwide in the US. The recall was initiated on 2 Jan 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-0375-2019
- FDA event ID
- 81888
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Cefdinir
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2019
- FDA classified
- 15 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 2 Jan 2019 | Recall initiated by company | |
| 15 Jan 2019 | Classified by FDA | +13 days |
| 16 Jan 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Product as listed by the FDA
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Which lots are affected?
a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019.
Where was it sold?
Nationwide within the United States
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.
Other products in this recall event
1 other product · FDA event 81888| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cefdinir for Oral Suspension USP, 250mg recalledCefdinir | Lupin Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
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 |