RecallRadar

FDA Drug recall D-0380-2019

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Mary…

On 2019-01-23 the FDA classified a Class II recall of Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Mary… by Lupin Pharmaceuticals, citing CGMP Deviation; manufacturing batch record could not be located.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0380-2019
ClassificationClass II
Statusterminated
Initiated2019-01-07
Published2019-01-23
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

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

Reason

CGMP Deviation; manufacturing batch record could not be located

Identifiers

code_infolot # F602820, Expiry December 2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0380-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.