Sulfamethoxazole and Trimethoprim Tablets — Class II drug recall D-0572-2016
Terminated recall by Mutual Pharmaceutical Company, Inc., reported 2016-01-27, distributed in MS. Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on th
| Recall number | D-0572-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mutual Pharmaceutical Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2015-10-09 |
| Classified | 2016-01-19 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-10-13 |
| Distributed | MS |
| Quantity | 9,526 |
| NDC | 53489-0146-01 |
| Lot numbers | 01/18, 6727001 |
Product
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
Reason for recall
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
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-0572-2016. 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.