Dexamethasone Elixir Recalled for Impurities Above Permissible Levels
Morton Grove Pharmaceuticals is recalling Dexamethasone Elixir USP 0.5 mg/5 mL nationwide due to unknown impurities found at higher than permissible levels in affected lots.
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 involving impurity/degradation specifications. The source text does not report any illnesses, hospitalizations, or injuries; the hazard is chemical/quality-control based and precautionary in nature, making this a moderate-severity recall.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling Dexamethasone Elixir, USP 0.5 mg/5 mL (8 fl oz / 237 mL bottles) due to failed impurities and degradation specifications. Testing identified unknown impurities in the drug product at levels exceeding what is permissible.
The affected lots are: UV1004, UV1005 (expiration 6/22); UW1014, UW1015 (expiration 1/23); and UW1084 (expiration 7/23). This product is distributed nationwide in the USA and Puerto Rico.
Consumers who have received this medication should contact their healthcare provider or pharmacist for guidance. Patients should not stop taking their medication without medical advice.
The recalled product
- Product
- Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
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 (8)
- Lot #s: UV1004
- UV1005
- Exp 6/22
- UW1014
- UW1015
- Exp 1/23
- UW1084
- Exp 7/23
Distribution
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