Amoxicillin for Oral Suspension — Class III drug recall D-598-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-06-19, distributed nationwide. Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the
| Recall number | D-598-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-04-26 |
| Classified | 2013-06-11 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 758,554 bottles |
| Reason classes | packaging |
| NDC | 00093-2263, 00093-2263-01, 00093-2264, 00093-2264-01, 00093-2267, 00093-2267-01, 00093-2268, 00093-2268-01, 00093-3107, 00093-3107-01, 00093-3107-05, 00093-3109, 00093-3109-05, 00093-3109-53, 00093-4155, 00093-4155-73, 00093-4155-79, 00093-4155-80, 00093-4160, 00093-4160-73, 00093-4160-76, 00093-4160-78, 00093-4161, 00093-4161-73, 00093-4161-76 and 1 more |
| Lot numbers | 35426081A, 35426082A, 35426083A, 35426084A, 35426631A, 35426632A, 35426633A, 35426634A, 35426635A, 35426636A, 35426637A, 35426638A, 35426639A, 35426640A, 35426641A, 35426642A, 35426648A, 35426680B, 35426681B, 35426682B, 35427222A, 35427223A, 35427224A, 35427226A, 35427227A, 35427228A |
| Expiration dates | 2014-06, 2014-08, 2014-09, 2014-10 |
Product
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Reason for recall
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
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-598-2013. 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.