CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg recalled
AuroMedics Pharma is recalling Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, distributed nationwide in the US. The recall was initiated on 7 Feb 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0852-2020
- FDA event ID
- 84910
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2020
- FDA classified
- 19 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antibiotics
Timeline
| 7 Feb 2020 | Recall initiated by company | |
| 19 Feb 2020 | Classified by FDA | +12 days |
| 19 Feb 2020 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Which lots are affected?
Lot #: SM8719040-A, Exp. Date 02/2021
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 30 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AuroMedics Pharma
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|---|---|---|---|---|---|
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| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
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Other Amoxicillin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amoxicillin and Clavulanate Potassium recalled | Teva Pharmaceuticals USA | Potency & Assay | CA, MS, OH |
| Drug | CLASS II | Amoxicillin and Clavulanate Potassium Tablets recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 400MG/ (when reconstituted) recalledAmoxicillin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin Tablets, USP, 875MG recalled by Cardinal HealthcareAmoxicillin | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Amoxicillin Capsules, USP, 500 mg recalled by Mckesson Medical-SurgicalAmoxicillin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |