Akorn Recalls Sulfamethoxazole/Trimethoprim Suspension Due to Dissolution Failure
Akorn recalls specific lots of grape-flavored antibiotic suspension because they failed dissolution specifications. Check your bottle's lot number and expiration date.
Use caution until it’s fixed
Failed Dissolution Specifications
Contact the company
What happened, in plain English
Akorn, Inc. is recalling Sulfamethoxazole and Trimethoprim Oral Suspension, USP in a 16 fl oz grape flavor due to failed dissolution specifications. The recall affects 55,968 bottles distributed nationwide. The record does not specify the exact remedy or what consumers should do with the product. Read more at govinfonow.com/recall/41814-akorn-recalls-sulfamethoxazole-trimethoprim-suspension-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/41814-akorn-recalls-sulfamethoxazole-trimethoprim-suspension-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0696-2017
Cite this page
“Akorn Recalls Sulfamethoxazole/Trimethoprim Suspension Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41814-akorn-recalls-sulfamethoxazole-trimethoprim-suspension-due-to-dissolution-failure. Based on FDA recall #D-0696-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0696-2017%22&limit=1).
Why it’s dangerous
The product failed dissolution specifications, meaning the active ingredients may not release from the tablet or liquid in the way intended. This could result in the medication not working effectively to treat the infection it was prescribed for.
Who’s affected
Patients prescribed this specific antibiotic suspension by a healthcare provider who received one of the recalled lots. Because it is an Rx-only medication, the risk is primarily to those relying on its efficacy for treating bacterial infections.
How to tell if you have this one
Check your bottle for the following details: Brand Akorn; Product Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL; Grape Flavor; Rx Only; 16 fl oz (473 mL). Look for NDC 50383-824-16. Affected lots are 348913 (Exp. 01/18), 349552, 349681, 349683, 349685, 349687, 349689, and 350636 (all Exp. 03/18).
- Brand
Akorn- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your bottle matches the NDC 50383-824-16 and one of the listed lot numbers with expiration dates in January or March 2018.
Contact Your Pharmacist
Since the remedy is not stated in the record, contact your pharmacy or healthcare provider to determine if you need a replacement prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0696-2017 (March 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0696-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.