Sulfamethoxazole and Trimethoprim Oral Suspension — Class II drug recall D-0696-2017
Terminated recall by Akorn Inc, reported 2017-05-10, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0696-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2017-03-13 |
| Classified | 2017-05-04 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 55,968 bottles |
| Reason classes | specification failure |
| NDC | 50383-0824-16 |
| Lot numbers | 01/18, 03/18, 348913, 349552, 349681, 349683, 349685, 349687, 349689, 350636 |
Product
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
Reason for recall
Failed Dissolution Specifications
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-0696-2017. 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.