# FDA recall D-1535-2020

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2020-08-10.

## Product

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.

## Reason for recall

Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-1535-2020
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-08-10
- **Report date:** 2020-09-02
- **Termination date:** 2024-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1535-2020

## Citation

> AI Analytics. FDA recall D-1535-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1535-2020. Source: US FDA. Licensed CC0.

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