Valproic Acid Oral Solution recalled for microbial contamination
Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text identifies a CGMP deviation and potential microbial contamination but does not report any illnesses, injuries, or hospitalizations. The hazard is present but not yet manifested in actual harm, making this a precautionary recall consistent with a Moderate severity rating.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling Valproic Acid Oral Solution USP (250 mg/5 mL), 1 Pint (473 mL) bottles, NDC 60432-621-16, Lot #UV1159, manufactured for Wockhardt USA, LLC. The recall stems from potential contamination with microbial organisms in liquid sugar batches used in the manufacturing process, representing a deviation from good manufacturing practices (CGMP).
The affected product was distributed nationwide in the USA and China. A total of 38,748 bottles are subject to this recall.
Consumers and healthcare providers in possession of this product should stop using it immediately. Patients currently taking this medication should consult their healthcare provider before discontinuing use, as abrupt cessation of valproic acid can be medically dangerous. Healthcare providers and patients should contact their pharmacy or Morton Grove Pharmaceuticals for instructions on product return or replacement.
The recalled product
- Product
- Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 38,748
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: UV1159
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Morton Grove Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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