RecallRadar

FDA Drug recall D-0306-2020

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only,…

On 2019-11-13 the FDA classified a Class III recall of Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only,… by Lupin Pharmaceuticals, citing presence of Foreign substance: identified as a dead ant.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0306-2020
ClassificationClass III
Statusterminated
Initiated2019-11-01
Published2019-11-13
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

Reason

Presence of Foreign substance: identified as a dead ant.

Identifiers

ndc68180-722-20
ndc68180-722-10
ndc68180-722-04
ndc68180-722-05
ndc68180-723-20
ndc68180-723-10
ndc68180-723-04
ndc68180-723-05
code_infoLot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20

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-0306-2020%22

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