Morton Grove Pharmaceuticals recalls Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches. This prescription medication may pose a risk if used without proper handling.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Morton Grove Pharmaceuticals has recalled Valproic Acid Oral Solution (25:00 mg/5 mL) because it was made using liquid sugar batches that might have microbial contamination. This could pose a health risk if the medication is used without proper handling.
The medication was produced using liquid sugar batches that may contain microbial organisms. This contamination could lead to infections or other health issues if the medication is used without proper hygiene and handling.
Prescription patients using Valproic Acid Oral Solution (250 mg/5 mL) manufactured by Morton Grove Pharmaceuticals for Wockhardt USA, LLC. Those with epilepsy or other conditions requiring this medication are most at risk.
Check for the product name 'Valproic Acid Oral Solution USP', strength 250 mg/5 mL, and 1 pint (473 mL) size. The NDC code is 60432-621-16 and lot number UV1159.
Look for the NDC code 60432-621-16 and lot number UV1159 on the label.
The recall states there is a potential concern with microbial contamination, so it is not recommended to use this product without contacting the manufacturer first.
The recall record does not specify a remedy or replacement process.
The recall record does not provide specific instructions for what to do with the product.
We’ve drafted a message you can send Morton Grove Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0816-2021 — Morton Grove Pharmaceuticals Morton Grove Pharmaceuticals Hello, I own a Morton Grove Pharmaceuticals that is covered by recall D-0816-2021 from Morton Grove 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.
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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.