Amoxicillin For Oral Suspension — Class III drug recall D-1515-2016
Terminated recall by West-Ward Pharmaceuticals Corp., reported 2016-09-28, distributed nationwide. Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product
| Recall number | D-1515-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceuticals Corp., Eatontown, NJ, United States |
| Recall initiated | 2016-08-18 |
| Classified | 2016-09-19 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-09-01 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 00143-9887-01 |
| Lot numbers | 11/18, AS1413A, AS1414A |
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,
Reason for recall
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1515-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.