FDA Drug recall D-803-2013
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufact…
- FDA Drug
- Class III
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class III recall of Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufact… by Teva Pharmaceuticals Usa, citing discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-803-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-06-18 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Reason
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
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 #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14 |
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-803-2013%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.