SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION — Class II drug recall D-0995-2015
Terminated recall by Akorn, Inc., reported 2015-05-20, distributed nationwide. Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
| Recall number | D-0995-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-03-17 |
| Classified | 2015-05-08 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 50383-0823-16 |
| Lot numbers | 623940, 624487, 624741, 625296 |
| Expiration dates | 2015-10, 2015-11, 2016-01 |
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
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-0995-2015. 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.