FDA Drug recall D-1470-2016
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada,…
- FDA Drug
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada,… by Teva North America, citing superpotent drug: Out of specification test result for assay during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1470-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-24 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva North America |
| Distribution | US |
Product
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Reason
Superpotent drug: Out of specification test result for assay during stability testing.
Identifiers
| ndc | 0093-2263-01 |
|---|---|
| ndc | 0093-2264-01 |
| ndc | 0093-4160-76 |
| ndc | 0093-4160-78 |
| ndc | 0093-4160-73 |
| ndc | 0093-4155-79 |
| ndc | 0093-4155-73 |
| ndc | 0093-4155-80 |
| ndc | 0093-4161-76 |
| ndc | 0093-4161-78 |
| ndc | 0093-4161-73 |
| ndc | 0093-2267-01 |
| ndc | 0093-2268-01 |
| ndc | 0093-3107-01 |
| ndc | 0093-3107-05 |
| ndc | 0093-3109-53 |
| ndc | 0093-3109-05 |
| code_info | Lot # 35434158A, Exp 6/17 |
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-1470-2016%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.