SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION — Class II drug recall D-0996-2015

Terminated recall by Akorn, Inc., reported 2015-05-20, distributed nationwide. Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Recall number	`D-0996-2015`
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	`50383-0824-16`
Lot numbers	`618358`, `618646`, `618649`, `618652`, `618746`, `618749`, `618934`, `618940`, `618946`, `621496`, `621890`, `622779`, `623389`, `623829`, `623946`, `623952`, `623955`, `624147`, `624153`, `624159`, `624162`, `624271`, `624274`, `624490`, `624493`, `624496`, `624499`, `624744`, `624747`, `624750`, `624753`, `624836`, `624839`, `625120`, `625123`, `625126`, `625795`, `625918`, `625921`, `625924` and 5 more
Expiration dates	`2015-11-15`, `2015-11-18`, `2015-11-19`, `2015-11-20`, `2015-11-26`, `2015-11-27`, `2015-12-05`, `2015-12-06`, `2015-12-08`, `2016-05-13`, `2016-06-24`, `2016-07-27`, `2016-08-31`, `2016-09-27`, `2016-10-02`, `2016-10-03`, `2016-10-08`, `2016-10-09`, `2016-10-15`, `2016-10-17`, `2016-10-18`, `2016-10-23`, `2016-10-25`, `2016-11-06`, `2016-11-08` and 13 more

Product

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), 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-0996-2015. 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.