Amneal recalls 100-count Extended Phenytoin Sodium Capsules (100 mg) due to failed dissolution specifications. This may affect medication effectiveness. Check NDC# 65162-212-10 and lot numbers for affected products.
Failed Dissolution Specifications
Amneal is recalling 100-count bottles of Extended Phenytoin Sodium Capsules (100 mg) because they failed dissolution tests. This could mean the medication doesn't work properly as intended, which is serious for people taking it for seizures.
The capsules failed dissolution specifications, meaning they may not release the medication properly in the body. This could lead to inconsistent blood levels of the drug, potentially affecting seizure control.
People who take extended phenytoin sodium capsules for seizure management are likely affected. Those with the specific NDC number and lot number are at highest risk.
Check for the NDC number 65162-212-10 and lot number HM03221A on the bottle. The product was distributed by Amneal Pharmaceuticals LLC and sold between 2023 and 2024.
Look for NDC# 65162-212-10 and lot number HM03221A on the bottle.
The recall is due to failed dissolution specifications, which may affect medication effectiveness but does not indicate immediate danger to health.
Check for NDC# 65162-212-10 and lot number HM03221A on the bottle. The product was distributed by Amneal Pharmaceuticals LLC.
The recall does not specify a remedy, so contact Amneal Pharmaceuticals for guidance.
We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.
Subject: Recall D-0090-2024 — Amneal Amneal Hello, I own a Amneal that is covered by recall D-0090-2024 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.
