PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported February 19, 2020

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

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

Recall #
D-0852-2020
Affected scope
30432 bottles
Initiated
February 7, 2020
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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AuroMedics Pharma LLC recalled Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Dist… - a moderate-severity action.

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Dist… was recalled by AuroMedics Pharma LLC in February 19, 2020. Reason: Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie. Check the official notice for the remedy. Verify recall #D-0852-2020 with the FDA Drug before acting.

The recall

AuroMedics Pharma LLC issued this moderate-severity FDA Drug recall-Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie.

Moderate
severity level
Class II
classification
February 19, 2020
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0852-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0852-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on February 7, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. AuroMedics Pharma LLC is listed as the recalling firm, operating out of East Windsor, NJ. Federal records list the affected scope as 30432 bottles.

The documented reason for this recall is: Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Electronics recalls over time

Where this recall sits in its category - 609 electronics recalls on record

1020304050 20052008201120142017202020232026 36
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

30432 bottles

Related Recalls

6

0 from same agency

Product description

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

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0852-2020
Date reported February 19, 2020
Date initiated February 7, 2020
Recalling firm AuroMedics Pharma LLC
Firm location East Windsor, NJ
Affected scope 30432 bottles
Distribution Nationwide within the United States

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0852-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by AuroMedics Pharma LLC. Units affected: 30432 bottles.
Why was this product recalled?
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0852-2020.
Where was the recalled product distributed?
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0852-2020) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 19, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.