Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0546-2023·Announced 2023-05-03

DuPont Avicel PH-200 NF pharmaceutical ingredient recalled for conductivity specification failure

DuPont is recalling Avicel PH-200 NF microcrystalline cellulose, a pharmaceutical ingredient, for failing conductivity specifications. The bulk ingredient was distributed to drug manufacturers in the USA and internationally.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III pharmaceutical ingredient recall with out-of-specification conductivity results. No illnesses or injuries have been reported. The specification failure could affect pharmaceutical quality but does not indicate an immediate safety hazard.

Plain-English summary

DuPont Nutrition USA, Inc. is recalling Avicel PH-200 NF (microcrystalline cellulose NF), a pharmaceutical ingredient used in drug manufacturing. The recall involves approximately 93,660 kg distributed in bulk containers.

The recall was initiated because quality testing identified out-of-specification conductivity results in the affected batches. This specification failure may impact the quality of pharmaceutical products manufactured with this ingredient.

The affected batches (Batch Numbers: 2173766945, 2173768895, PN20834306, 217373201, PN20834301) were distributed to pharmaceutical manufacturers in the USA and internationally, including Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, the Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Colombia.

The recalled product

Product: Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 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…
Manufacturer: DuPont Nutrition USA, Inc
Category: Drug — Pharmaceutical Ingredient / Excipient
Hazard: specification-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Batch Numbers: 2173766945
2173768895
PN20834306
217373201
PN20834301

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by DuPont Nutrition USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · DuPont Nutrition USA, Inc

See all →

Moderate
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FDA (Drugs) · 2023-05-03
Moderate
DuPont Avicel DG pharmaceutical ingredient recalled for failed quality specification
FDA (Drugs) · 2023-05-03
Low
FDA recalls Avicel PH-102 microcrystalline cellulose bulk ingredient for specification failure
FDA (Drugs) · 2023-05-03
Low
Avicel PH-200 pharmaceutical excipient recalled for failed conductivity specification
FDA (Drugs) · 2023-03-08
Moderate
DuPont Avicel PH-102 Microcrystalline Cellulose Recalled for Conductivity Specification Failure
FDA (Drugs) · 2023-03-08

Same hazard · specification failure