Amoxicillin Oral Suspension (Teva) – Powder Discoloration (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Brand
Teva Pharmaceuticals USA, Inc.
Lot Codes / Batch Numbers
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, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014, 35426641A, 35426642A, Exp 09/2014.
Products Sold
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, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014.
Teva Pharmaceuticals USA, Inc. is recalling Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL) due to Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026