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,

Recall Insight

This FDA Drug action (record #D-1515-2016) was formally reported on September 28, 2016, with the manufacturer initiating the action on August 18, 2016. It is classified under Low severity (Class III), with a current status of Terminated. West-Ward Pharmaceuticals Corp. is listed as the recalling firm, operating out of Eatontown, NJ. Federal records indicate 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.