Folic Acid tablets recalled for improper storage conditions
Cardinal Healthcare recalls Folic Acid tablets (1mg, batch H08221) nationwide due to storage temperature deviations during manufacturing. No illnesses reported.
What this means for you
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 a CGMP procedural deviation. No illnesses, injuries, or hospitalization have been reported. The hazard is theoretical rather than demonstrating direct harm.
Plain-English summary
Cardinal Healthcare is recalling Folic Acid tablets, USP 1mg (NDC 69315-127-10), batch H08221, manufactured by Leading Pharma, LLC. The recall is due to Good Manufacturing Practice (CGMP) deviations—products were exposed to temperatures outside of the labeled storage conditions.
The affected product was distributed nationwide. No illnesses or injuries have been reported in association with this recall.
Consumers who have purchased affected products should discontinue use and contact their pharmacist or healthcare provider for guidance on obtaining a replacement from an approved source.
The recalled product
- Product
- FOLIC ACID (FOLIC ACID)
- Brand
- FOLIC ACID
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Prescription Vitamin
- Affected units
- 1
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)
- Batch H08221
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE 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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