Akorn recalls all 50mL Ferrous Sulfate Iron Supplement Drops due to stability concerns after the manufacturer went out of business and could no longer conduct stability testing.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all 50mL Ferrous: Sulfate Iron Supplement Drops because the manufacturer went out of business and can no longer ensure the product's stability. This means the product may not be safe for use as it could degrade over time.
The manufacturer went out of business and could no longer perform stability studies to ensure the product remains safe and effective over time. Without ongoing testing, the iron supplement may degrade, potentially causing safety issues.
People who own or use Akorn's Ferrous Sulfate Iron Supplement Drops in 50mL bottles are affected. Those with iron deficiency who rely on these drops for treatment are most at risk.
Check for Akorn Ferrous Sulfate Iron Supplement Drops in 50mL bottles. All products, including all National Drug Codes (NDCs) and all lots, are affected.
Look for the product name and packaging to confirm it's the affected 50mL Ferrous Sulfate Iron Supplement Drops.
Reach out to Akorn for guidance on next steps, though no specific remedy is provided in the recall notice.
The recall notice does not specify a time frame for use; the product is affected due to the manufacturer's closure and inability to conduct stability studies.
The recall indicates the product may not be safe due to stability issues, but the manufacturer has no longer been able to test it for safety.
The recall notice does not provide specific instructions for action; you should contact Akorn directly for guidance.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0803-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0803-2023 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.
