Cardinal Health Recalls Polyethylene Glycol 3350 Powder for Temperature Excursions
Cardinal Health Inc. is recalling 163 bottles of Polyethylene Glycol 3350 Powder for Solution due to intermittent exposure to temperature excursions during storage.
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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Cardinal Health Inc. is recalling 163 bottles of Polyethylene Glycol 3350 Powder for Solution, Laxative, Net Wt 4.1 oz (119 g), 7 Once-Daily Doses. The product is identified by NDC 45802-868-01 and is distributed by Perrigo in Allegan, MI. The recall covers all lots distributed between February 23, 2021, and March 10, 2021.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.
Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)
- Brand
- POLYETHYLENE GLYCOL 3350
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — OTC Laxative
- Affected units
- 163
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)
- All Lots distributed 02/23/2021 through 03/10/2021.
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health 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.
See all 198 products in this recall →Related recalls
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