Amoxicillin Suspension (West-Ward) – Missing Label Panel (2016)
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 - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
Brand
West-Ward Pharmaceuticals Corp.
Lot Codes / Batch Numbers
Lot #: AS1413A, AS1414A, Exp. 11/18
Products Sold
Lot #: AS1413A, AS1414A; Exp. 11/18
West-Ward Pharmaceuticals Corp. is recalling Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, due to Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.. 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
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
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