# FDA recall D-0802-2018

> **Sun Pharmaceutical Industries, Inc.** · Class II · drug recall initiated 2018-04-19.

## Product

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05

## Reason for recall

Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.)  because a foreign matter identified as polyethylene was detected in two (2) tablets.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0802-2018
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-19
- **Report date:** 2018-05-23
- **Termination date:** 2019-02-28

- **Voluntary/Mandated:** —
- **Location:** Cranbury, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0802-2018

## Citation

> AI Analytics. FDA recall D-0802-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0802-2018. Source: US FDA. Licensed CC0.

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