Teva Recalls Amoxicillin Powder Due to Discoloration on Inner Foil Seal
Teva Pharmaceuticals is recalling Amoxicillin for Oral Suspension due to yellow to brown discoloration on the inner foil seal.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for cosmetic or packaging issues.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Amoxicillin for Oral Suspension, USP 400mg/5mL. The recall involves 758,554 bottles distributed nationwide. The specific products affected are NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL).
The recall is being carried out due to a yellow to brown discolored Amoxicillin powder found on the inner foil seal of the bottles. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers should check their medication for the specific NDC numbers and lot numbers listed in the official recall notice. If the product matches the recalled items, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 758,554
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 (20)
- a) NDC 0093-4161-78 -- lot numbers 35426081A
- 35426082A
- 35426083A
- 35426084A
- Exp: 06/2014
- 35426648A
- Exp 08/2014
- 35427222A
- 35427224A
- 35427226A
- 35427223A
- 35427227A
- 35427228A
- Exp 10/2014
- and b) NDC 0093-4161-73 -- lot numbers 35426631A
- 35426632A
- 35426633A
- 35426634A
- 35426635A
- 35426636A
UPCs (9)
- 0300933107051
- 0300932264014
- 0300934161731
- 0300933109055
- 0300932267015
- 0300932268012
- 0300932263017
- 0300934160734
- 0300934155730
Distribution
Distributed nationwide across the United States.
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