Akorn Antibiotic Suspension Recalled Due to CGMP Deviations and Unverified Stability
Akorn recalls all lots of Sulfamethoxazole & Trimethoprim Oral Suspension (200mg/40mg per 5mL) nationwide due to inability to complete required stability studies after the company ceased operations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a precautionary Class II FDA recall due to CGMP deviations (incomplete stability studies). No illnesses, injuries, or confirmed quality failures have been reported. The recall stems from the manufacturer's closure preventing continuation of required regulatory compliance activities.
Plain-English summary
Sulfamethoxazole and trimethoprim is an oral antibiotic suspension available in 473mL bottles with cherry flavoring, distributed nationwide in the USA and Puerto Rico. This is an Rx-only medication manufactured by Akorn, Inc.
Akorn initiated the recall of all lots after the company went out of business and could no longer complete stability studies required under FDA Good Manufacturing Practice (CGMP) regulations. Stability studies assess whether medications maintain their intended strength and purity under normal storage and handling conditions throughout their shelf life.
Patients should consult their healthcare provider or pharmacist regarding any prescribed medication affected by this recall. Healthcare providers can help determine next steps, which may include continuing the current supply if adequate, obtaining a replacement from an alternative manufacturer, or other clinically appropriate alternatives.
The recalled product
- Product
- Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Hazard
- cgmp-deviation
- stability-unverified
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27