Teva Recalls Amoxicillin Oral Suspension Due to Potency Issues
Teva North America is recalling Amoxicillin for Oral Suspension because stability testing showed the drug was superpotent.
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: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a potency deviation without reported injuries.
Plain-English summary
Teva North America is recalling 53,328 bottles of Amoxicillin for Oral Suspension USP, 400 mg/5 mL, 50 mL bottle. The product is identified by Lot # 35434158A and has an expiration date of 6/17. It was distributed nationwide.
The recall was initiated because the drug failed to meet specifications for assay during stability testing, resulting in a superpotent drug. This means the medication contained more active ingredient than intended.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- Teva North America
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 53,328
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 (2)
- Lot # 35434158A
- Exp 6/17
UPCs (9)
- 0300933107051
- 0300932264014
- 0300934161731
- 0300933109055
- 0300932267015
- 0300932268012
- 0300932263017
- 0300934160734
- 0300934155730
Distribution
Distributed nationwide across the United States.
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