CLASS II Drug recall · Reported 23 Jan 2019 · FDA Enforcement Report
Cephalexin for Oral Suspension USP, 250mg/ (when mixed) recalled
Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension USP, 250mg/ (when mixed), distributed nationwide in the US. The recall was initiated on 7 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-0380-2019
- FDA event ID
- 81898
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2019
- FDA classified
- 16 Jan 2019
- Reported
- 23 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 7 Jan 2019 | Recall initiated by company | |
| 16 Jan 2019 | Classified by FDA | +9 days |
| 23 Jan 2019 | 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
CGMP Deviation; manufacturing batch record could not be located
Product as listed by the FDA
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
Where it was distributed
Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
Questions about this recall
Why was it recalled?
CGMP Deviation; manufacturing batch record could not be located
Which lots are affected?
lot # F602820, Expiry December 2019
Where was it sold?
Product was distributed to 12 major distributors who may have further distributed the product throughout 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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Other Cephalexin For recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cephalexin for Oral Suspension USP, 250 mg recalled | Lupin Pharmaceuticals | Other | Nationwide |