Amoxicillin tablets recalled due to improper storage temperature exposure
Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves medications exposed to improper storage temperatures, which presents a risk of reduced drug efficacy. No illnesses or injuries have been reported, but the hazard to patient health is documented as a manufacturing deviation.
Plain-English summary
Cardinal Healthcare is recalling Amoxicillin 875mg tablets in 20-tablet packages due to Current Good Manufacturing Practice (CGMP) deviations. Products in batch LJ9004 were exposed to temperatures outside the labeled storage conditions during manufacturing or distribution.
The affected products were distributed nationwide in the United States. Consumers should verify the batch number (LJ9004) on their medication packaging to determine if they have a recalled product.
Consumers who have this medication are advised to consult with their healthcare provider or pharmacist before continuing use. Return the recalled medication to your pharmacy or follow local medication disposal instructions.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Oral Antibiotic
- Affected units
- 2
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 LJ9004
UPCs (8)
- 0307816156526
- 0307812020012
- 0307816041587
- 0307815060015
- 0307815061012
- 0307816157523
- 0307816039584
- 0307812613016
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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