Amoxicillin Suspension (Teva) – Subpotent Product (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lots: (a) Lot # 35436769A, exp. date 05/2019, 35438389A, 35438390A, exp. date 01/2020, 35440838A, exp. date 10/2020, (b) 35437491A, 35443574B, exp. date 09/2021
Products Sold
Lots: (a) Lot # 35436769A, exp. date 05/2019; 35438389A, 35438390A, exp. date 01/2020; 35440838A, exp. date 10/2020; (b) 35437491A, 35443574B, exp. date 09/2021
Teva Pharmaceuticals USA is recalling Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-8 due to Subpotent Product: assay results for Amoxicillin were below the specification limits.. 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
Subpotent Product: assay results for Amoxicillin were below the specification limits.
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