Glenmark Pharmaceuticals recalls 2.5mg Fluphenazine Hydrochloride tablets due to CGMP deviations. Affected units: 100-count bottles with NDC 68462-336-01, lot 17232214, expiring Sep 2025.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 2.5mg Fluphen: 100-count tablets that were manufactured with CGMP deviations. This recall affects prescription-only medication bottles sold in the US. The issue could lead to improper drug quality or safety risks if the tablets are used without proper manufacturing controls.
CGMP deviations refer to failures in the manufacturing process that could affect the quality, safety, or purity of the medication. This means the tablets might not meet the required standards for effectiveness or safety, potentially leading to improper treatment or adverse effects.
Prescription holders of Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottles with NDC 68462-336-01 and lot number 17232214 are affected. Patients using these tablets for mental health conditions may be at risk if the product was manufactured with CGMP deviations.
Check for the NDC code 68462-336-01 on the product label. The lot number 17232214 and expiration date of September 2025 are also specific identifiers for this recall.
Look for the NDC code 68462-336-01 and lot number 17232214 on the tablet packaging.
Yes, this recall is for Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottles with NDC 68462-336-01.
CGMP deviations indicate manufacturing process failures that could affect the quality, safety, or purity of the medication.
Check for the NDC code 68462-336-01 and lot number 17232214 on the product label.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0327-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0327-2025 from Glenmark. 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.
