RecallRadar

FDA Drug recall D-0868-2017

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for…

On 2017-06-07 the FDA classified a Class III recall of Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for… by Sandoz, citing subpotent Drug; Clavulanic Acid.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0868-2017
ClassificationClass III
Statusterminated
Initiated2017-04-26
Published2017-06-07
Last updated2026-09-13 11:51 UTC
CompanySandoz
DistributionNY, OH

Product

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20

Reason

Subpotent Drug; Clavulanic Acid

Identifiers

ndc0781-1874-31
ndc0781-1831-20
ndc0781-1831-13
ndc0781-1831-01
ndc0781-1852-20
ndc0781-1852-13
ndc0781-1852-01
ndc0781-6102-46
ndc0781-6102-57
ndc0781-6102-52
ndc0781-6104-46
ndc0781-6104-57
ndc0781-6104-52
code_infoLot FP8735, 8/2017

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-0868-2017%22

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