ANI Pharmaceuticals recalls 1.0 mg Alprazolam tablets from specific bottle counts and lot numbers due to cGMP deviations. These prescription-only tablets may not meet quality standards.
cGMP Deviations
ANI Pharmaceuticals is recalling 1.0 mg Alprazolam tablets in specific bottle counts (100-count, 500-count, 1000-count) and lot numbers because of manufacturing quality deviations. This recall affects prescription-only tablets that may not meet safety standards.
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the tablets may not meet the required quality and safety standards during production. This could potentially affect the medication's effectiveness or safety, though the exact risk is not specified in the recall notice.
Prescription holders of the specific 1.0 mg Alprazolam tablets with the listed bottle counts and lot numbers are affected. People taking these medications should check their product details.
Check if your Alprazolam tablets are in 100-count, 500-count, or 1000-count bottles with the specific lot numbers listed (e.g., 19B081A, 19E088A, etc.). These tablets are prescription-only and distributed by Par Pharmaceutical.
Identify if your Alprazolam tablets match the recalled bottle counts and lot numbers listed in the recall notice.
The recall is due to cGMP deviations, which means the tablets may not meet quality and safety standards during manufacturing.
The recall notice does not specify a stop-use instruction; you should check if your tablets match the recalled details.
The recall notice does not provide a specific remedy; you should check the product details and contact your pharmacist or the manufacturer if needed.
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0566-2022 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0566-2022 from ANI Pharmaceuticals. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
