Glenmark Pharmaceuticals recalls 10mg Fluphenazine Hydrochloride tablets due to CGMP deviations. Affected units have NDC# 68462-338-01 and lot # 17232206. No specific remedy stated in recall notice.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 10mg Flup: 100-count bottles due to manufacturing deviations. This recall doesn't specify a safety risk or remedy, so it's unclear why the product is being taken off the market.
CGMP deviations refer to manufacturing process failures that could affect product quality. However, the recall notice doesn't specify what the deviations are or how they might impact safety.
Prescription patients who received the specific lot number of Fluphenazine tablets. Healthcare providers who dispensed these tablets may also be affected.
Check for the NDC code 68462-338-01 and lot number 17232206 on the product label. The product is a prescription-only 10mg Fluphenazine Hydrochloride tablet bottle.
Look for NDC# 68462-338-01 and lot # 17232206 on the label to confirm if you have the recalled item.
The recall notice states there were CGMP deviations, but does not specify what the deviations are or how they might affect safety.
The recall notice does not state any specific remedy or action required for affected products.
The recall notice does not describe any specific hazard or risk of injury.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0326-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0326-2025 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.
