Amoxicillin oral suspension recalled for temperature storage deviation
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension nationwide due to CGMP deviations. Products were exposed to temperatures outside their labeled storage conditions.
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 with no reported illnesses or injuries. The hazard involves potential product degradation from temperature exposure, which is theoretical with no confirmed adverse health effects. The recall represents a manufacturing quality issue identified during compliance review.
Plain-English summary
CARDINAL HEALTHCARE is recalling Amoxicillin for Oral Suspension USP, 400MG/5ML (100ML when reconstituted), manufactured by Teva Cana Limited and distributed by Cardinal Healthcare. The product was exposed to temperatures outside the range specified on the product label, which constitutes a CGMP deviation. Batch 35447184A is affected.
The product has been distributed nationwide. Consumers who have this product should check the batch number on their package to confirm whether it matches the recalled batch 35447184A. If the batch number matches, do not use the product and contact a pharmacist or healthcare provider for guidance.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Oral Suspension
- Hazard
- improper-storage
- temperature-deviation
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 35447184A
UPCs (9)
- 0300933107051
- 0300932264014
- 0300934161731
- 0300933109055
- 0300932267015
- 0300932268012
- 0300932263017
- 0300934160734
- 0300934155730
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · AMOXICILLIN
- HighAmoxicillin tablets recalled due to improper storage temperature exposure
FDA (Drugs) · 2024-01-03
- HighAmoxicillin capsules recalled due to temperature exposure during manufacturing
FDA (Drugs) · 2022-06-15
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27