RecallRadar

FDA Drug recall D-0298-2020

Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, C…

On 2019-11-06 the FDA classified a Class II recall of Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, C… by Taro Pharmaceuticals U, citing presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0298-2020
ClassificationClass II
Statusterminated
Initiated2019-09-27
Published2019-11-06
Last updated2026-09-13 11:52 UTC
CompanyTaro Pharmaceuticals U
DistributionUS

Product

Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8

Reason

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Identifiers

ndc51672-1385-8
ndc51672-1385-9
code_infoLot #: K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21

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-0298-2020%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.