Mylan recalls 333mg Acamprosate Calcium tablets due to failed dissolution specifications. This may affect medication effectiveness. Contact Mylan for details.
Failed Dissolution Specifications
Mylan is recalling 333 mg Acamprosate Calcium tablets that failed dissolution tests. This could mean the medication doesn't work properly when taken as prescribed.
The tablets failed to dissolve properly in the body, which could lead to inconsistent medication levels. This might affect how well the drug works for conditions like alcohol dependence.
Prescription patients using this specific tablet product. Those with medical conditions requiring precise medication timing may be at slightly higher risk.
Check for the product name 'Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets' with NDC number 0378-6333-80. The lot number is 3227809 and it expires October 2026.
Look for the NDC number 0378-6333-80 on the product label.
The recall is due to failed dissolution specifications, which may affect medication effectiveness. Consult your doctor for advice.
Check for the NDC number 0378-6333-80 and lot number 3227809 on the product label.
The recall does not specify a remedy, so contact Mylan directly for guidance.
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0774-2026 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0774-2026 from Mylan. 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.
