FDA Drug recall D-0423-2019

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by:…

FDA Drug
Class II
terminated
Published 2019-02-06

On 2019-02-06 the FDA classified a Class II recall of Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by:… by Lupin Pharmaceuticals, citing 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 su….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0423-2019
Classification	Class II
Status	terminated
Initiated	2019-01-09
Published	2019-02-06
Last updated	2026-09-13 11:52 UTC
Company	Lupin Pharmaceuticals
Distribution	US

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

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.

Identifiers

ndc	68180-123-01
ndc	68180-123-02
ndc	68180-124-01
ndc	68180-124-02
ndc	68180-440-01
ndc	68180-440-02
ndc	68180-441-01
ndc	68180-441-02
code_info	lot F801282, Expiry June 2020

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-0423-2019%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.