Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Seal Defect
Morton Grove Pharmaceuticals is recalling 38,280 bottles of Prednisolone Sodium Phosphate Oral Solution because the tamper-evident foil seal is not completely intact.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product might cause temporary or medically reversible adverse health consequences. The defect is a packaging integrity issue (foil seal) rather than a direct contamination or dosage error, fitting the Moderate severity criteria for minor labeling or packaging errors.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling 38,280 bottles of Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only. The product is identified by NDC 60432-212-08 and Lot US1259. The recall was initiated because the tamper-evident foil seal on the bottles is not completely intact.
The affected product was distributed nationwide in the United States. This recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who have this product should check the lot number and NDC code on their bottles. If the product matches the recalled lot, they should contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 38,280
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 US1259
Distribution
Distributed nationwide across the United States.
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