Reported May 23, 2018 · Terminated

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm,…

Sun Pharmaceutical Industries, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605

Is this the product you have?

  • Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg
  • byFrontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist
  • bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
Lot codes and dates
    • Lot 6848501
    • EXP 04/2020
Amount recalled
1,908 500-count bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new foreign material recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 28, 2019 · Data as of Sep 19, 5:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.