Avicel PH-101 NF — Class III drug recall D-0544-2023
Terminated recall by DuPont Nutrition USA, Inc, reported 2023-05-03, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
| Recall number | D-0544-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DuPont Nutrition USA, Inc, Newark, DE, United States |
| Recall initiated | 2023-04-13 |
| Classified | 2023-04-25 |
| Reported by FDA | 2023-05-03 |
| Terminated | 2024-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DO, ES, IE, IN, MT, MX, PE, SA, SG |
| Quantity | 464,050 kilograms |
| Reason classes | specification failure |
| Lot numbers | 2173739298, 2173740020, 2173771315, 2173809472, 2173811313, P120834254, P120834282, P120834305, P120834313, P120834324, P120834423, P120834437, P120834443, P120834476, P120834478 |
Product
Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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-0544-2023. 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.