Amoxicillin for Oral Suspension — Class III drug recall D-803-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-07-24, distributed nationwide. Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the
| Recall number | D-803-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-06-18 |
| Classified | 2013-07-17 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 109,080 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 |
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 for recall
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.
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-803-2013. 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.