FDA Recalls Miralax Osmotic Laxative Powder for Storage Deviations
The FDA recalled 67 bottles of Miralax laxative powder due to storage conditions that violated drug label specifications. The precautionary recall is due to potential product quality concerns from improper storage conditions.
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 with no reported illnesses or injuries. The issue is a CGMP/procedural violation (improper storage conditions) initiated as a precautionary measure, fitting the Moderate category for precautionary recalls without documented harm.
Plain-English summary
Miralax (Polyethylene Glycol 3350) is an over-the-counter osmotic laxative powder used to relieve constipation. The FDA is recalling 67 bottles of Miralax (17.9 ounces each, NDC 11523-7234-4) that were distributed nationwide by Mckesson Medical-Surgical Inc. The recall was initiated due to storage conditions that did not meet current good manufacturing practice (CGMP) requirements and violated the drug label specifications.
Products stored outside the conditions specified on the label may not maintain their intended quality or effectiveness. No illnesses or injuries have been reported in connection with this recall.
Consumers with recalled product should stop using it and consult their healthcare provider with any questions. Retailers should quarantine the affected units and arrange return to the supplier.
The recalled product
- Product
- MIRALAX (POLYETHYLENE GLYCOL 3350)
- Brand
- MIRALAX
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
- Affected units
- 67
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)
- Part# 11523723404
UPCs (2)
- 0041100820716
- 0041100564542
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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