Sulfamethoxazole and Trimethoprim Tablets USP — Class II drug recall D-0802-2018
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2018-05-23, distributed nationwide. Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets
| Recall number | D-0802-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2018-04-19 |
| Classified | 2018-05-11 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2019-02-28 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material |
| NDC | 53489-0145, 53489-0145-01, 53489-0145-05, 53489-0146, 53489-0146-01, 53489-0146-05 |
| Lot numbers | 6848501 |
| Expiration dates | 2020-04 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0802-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.