Amneal recalls 100mg phenytoin capsules with failed dissolution specs. This may not release medication properly. Check NDC 65162-212-10 and lot # HL00721A for affected units.
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Amneal is recalling phenytoin sodium capsules that failed dissolution tests. This means the medication might not work as intended, risking ineffective treatment for seizures.
The capsules failed dissolution tests, meaning they may not release the medication correctly. This could lead to ineffective seizure treatment if the drug isn't absorbed properly.
Prescription patients using the recalled capsules. Those with seizure conditions are most at risk if the medication doesn't work properly.
Check for NDC 65162-212-10 and lot number HL00721A on the bottle. The capsules are 100 mg, prescription-only, and come in 100-count bottles.
Look for NDC 65162-212-10 and lot number HL00721A on the bottle.
The capsules failed dissolution tests, meaning they may not release medication properly.
Check the NDC and lot number. If you have the recalled batch, contact Amneal for guidance.
This is a low-risk issue as the capsules may not work properly, but it could affect seizure treatment effectiveness.
We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.
Subject: Recall D-0876-2023 — Amneal Amneal Hello, I own a Amneal that is covered by recall D-0876-2023 from Amneal. 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.
