Cephalexin for Oral Suspension USP 250mg/5 mL — Class II drug recall D-0423-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-02-06, distributed nationwide. CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary packa
| Recall number | D-0423-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-01-09 |
| Classified | 2019-01-31 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2020-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 14,400 bottles |
| Reason classes | foreign material, cgmp |
| NDC | 68180-0123, 68180-0123-01, 68180-0123-02, 68180-0124, 68180-0124-01, 68180-0124-02, 68180-0440, 68180-0440-01, 68180-0440-02, 68180-0441, 68180-0441-01, 68180-0441-02 |
| Lot numbers | F801282 |
| Expiration dates | 2020-06-20 |
Product
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Reason for recall
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0423-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.