RecallRadar

FDA Drug recall D-1252-2020

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc

On 2020-04-29 the FDA classified a Class II recall of Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc by Lupin Pharmaceuticals, citing subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1252-2020
ClassificationClass II
Statusterminated
Initiated2020-04-15
Published2020-04-29
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

Reason

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Identifiers

ndc68180-405-01
ndc68180-407-03
ndc68180-407-04
ndc68180-416-08
ndc68180-416-11
ndc68180-423-11
ndc68180-423-08
code_infoLot #: F800779, Expiry 4/2020

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-1252-2020%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.