RecallRadar

FDA Drug recall D-1320-2019

Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, In…

On 2019-06-05 the FDA classified a Class II recall of Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, In… by Lupin Pharmaceuticals, citing complaint received of metal piece identified in the product bottle prior to the reconstitution.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1320-2019
ClassificationClass II
Statusterminated
Initiated2019-05-23
Published2019-06-05
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20

Reason

Complaint received of metal piece identified in the product bottle prior to the reconstitution.

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 # F802335, exp. date November 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-1320-2019%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.