FDA Drug recall D-1515-2016
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals,…
- FDA Drug
- Class III
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class III recall of Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals,… by West Ward Pharmaceuticals, citing labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1515-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-18 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceuticals |
| Distribution | US |
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
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Identifiers
| code_info | Lot #: AS1413A, AS1414A; Exp. 11/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1515-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.