FDA Drug recall D-598-2013
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
- FDA Drug
- Class III
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class III recall of Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL) by Teva Pharmaceuticals Usa, citing discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-598-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-04-26 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Reason
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
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 | a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35…a) NDC 0093-4161-78 -- lot numbers 35426081A, 35426082A, 35426083A, 35426084A, Exp: 06/2014; 35426648A, Exp 08/2014; 35427222A, 35427224A, 35427226A, 35427223A, 35427227A, 35427228A, Exp 10/2014; and b) NDC 0093-4161-73 -- lot numbers 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426680B, 35426681B, 35426682B, Exp 08/2014; 35426641A, 35426642A, Exp 09/2014. |
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-598-2013%22
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