CLASS II Drug recall · Reported 26 May 2021 · FDA Enforcement Report
Cefixime for Oral Suspension USP 100 mg/ HDPE recalled
Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension USP 100 mg/ HDPE, distributed nationwide in the US. The recall was initiated on 29 Apr 2021 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-0390-2021
- FDA event ID
- 87871
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Cefixime
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2021
- FDA classified
- 19 May 2021
- Reported
- 26 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 29 Apr 2021 | Recall initiated by company | |
| 19 May 2021 | Classified by FDA | +20 days |
| 26 May 2021 | Published in enforcement report | +7 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
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/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: F900787, Exp. Date 4/2021
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.
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|---|---|---|---|---|---|
| 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 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 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 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 |