RecallRadar

FDA Drug recall D-0852-2020

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princet…

On 2020-02-19 the FDA classified a Class II recall of Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princet… by Auromedics Pharma, citing presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0852-2020
ClassificationClass II
Statusterminated
Initiated2020-02-07
Published2020-02-19
Last updated2026-09-13 11:52 UTC
CompanyAuromedics Pharma
DistributionUS

Product

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20

Reason

Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie

Identifiers

ndc65862-501-30
ndc65862-501-05
ndc65862-502-20
ndc65862-502-05
ndc65862-503-20
ndc65862-503-01
code_infoLot #: SM8719040-A, Exp. Date 02/2021

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-0852-2020%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.