CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg recalled
Sun Pharmaceutical Industries is recalling Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, distributed nationwide in the US. The recall was initiated on 19 Apr 2018 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-0802-2018
- FDA event ID
- 79909
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2018
- FDA classified
- 11 May 2018
- Reported
- 23 May 2018
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Antibiotics
Timeline
| 19 Apr 2018 | Recall initiated by company | |
| 11 May 2018 | Classified by FDA | +22 days |
| 23 May 2018 | Published in enforcement report | +12 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: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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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.
Which lots are affected?
Lot 6848501, EXP 04/2020
Where was it sold?
Nationwide in the USA
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 28 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sulfamethoxazole recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim | Northwind Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS I | Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And Trimethoprim | Amneal Pharmaceuticals | Sterility | Nationwide |