RecallRadar

FDA Drug recall D-0147-2017

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 18…

On 2016-11-30 the FDA classified a Class III recall of Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 18… by West Ward Pharmaceuticals, citing labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0147-2017
ClassificationClass III
Statusterminated
Initiated2016-11-04
Published2016-11-30
Last updated2026-09-13 11:51 UTC
CompanyWest Ward Pharmaceuticals
DistributionUS

Product

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01

Reason

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Identifiers

ndc0143-9886-01
ndc0143-9886-50
ndc0143-9886-75
ndc0143-9887-01
ndc0143-9887-50
ndc0143-9887-75
code_infoLot #: AS1466A, Exp. Jan 2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0147-2017%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.