Amoxicillin and Clavulanate Potassium Tablets — Class II drug recall D-0852-2020
Terminated recall by AuroMedics Pharma LLC, reported 2020-02-19, distributed nationwide. Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
| Recall number | D-0852-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2020-02-07 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2022-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 30,432 bottles |
| NDC | 65862-0503-20 |
| Lot numbers | SM8719040-A |
| Expiration dates | 2021-02 |
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 for recall
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0852-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.