Akorn recalls cherry-flavored sulfamethoxazole and trimethoprim oral suspension due to inability to conduct stability studies after going out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling cherry-flavored sulfamethoxazole and trimethoprim oral suspension bottles because the manufacturer went out of business and can no longer ensure the product's stability. This means the medication may not be safe for use after the expiration date.
The manufacturer went out of business and could no longer perform stability testing on the product. This means the medication might degrade over time, potentially reducing its effectiveness or causing safety issues if used after the expiration date.
People who have the cherry-flavored 473mL bottles of sulfamethoxazole and trimethoprim oral suspension (Rx only) are affected. Those using the medication for infections like UTIs or bacterial infections are most at risk if the product is unstable.
Check for cherry-flavored 473mL bottles labeled 'Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL' with Rx only. All NDCs and lots are affected.
Identify the product by checking the label for the specific cherry-flavored 473mL bottle with 200mg/40mg per 5mL and Rx only.
The manufacturer went out of business and could no longer continue stability studies, which means the product's safety and effectiveness cannot be guaranteed.
The recall record does not specify a remedy, so there is no action required beyond checking if you have the product.
The product may not be safe after the expiration date due to the manufacturer's inability to perform stability testing.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0848-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0848-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
