RecallRadar

FDA Drug recall D-1868-2019

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1)…

On 2019-09-25 the FDA classified a Class II recall of Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1)… by Aurolife Pharma, citing failed Impurities/Degradation Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1868-2019
ClassificationClass II
Statusterminated
Initiated2019-08-23
Published2019-09-25
Last updated2026-09-13 11:52 UTC
CompanyAurolife Pharma
DistributionUS

Product

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

Reason

Failed Impurities/Degradation Specifications

Identifiers

code_infoLot #s: a) 067180016B, Exp 05/21 and b) 067180024F1, Exp 07/21

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-1868-2019%22

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