The Recall Desk
ModerateFDA (Drugs)·D-0728-2021·Announced 2021-08-25

Avicel Microcrystalline Cellulose Recall for Out-of-Specification Conductivity

DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose (bulk PH101 NF, PH102 NF, PH200 NF) due to out-of-specification conductivity results. The product was distributed nationwide and internationally.

What this means for you

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 recall involving a specification failure in a pharmaceutical excipient. The source text does not report any illness, injury, or confirmed harm. This qualifies as a moderate-severity precautionary recall of a manufacturing or specification issue without evidence of patient impact.

Plain-English summary

DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose products packaged in bulk forms PH101 NF, PH102 NF, and PH200 NF due to out-of-specification results for conductivity. A total of approximately 2,384,720 kg has been affected.

The recall involves 47 lot numbers identified in the FDA notice. The affected lots do not have an expiration date. The product was distributed nationwide, including Puerto Rico, and to foreign accounts abroad.

Consumers and pharmaceutical manufacturers who have received these products should contact DuPont Nutrition USA, Inc. at 1301 Ogletown Road, Newark, DE 19711 regarding the recall. The source text does not specify what actions consumers should take beyond contacting the manufacturer.

The recalled product

Product
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Manufacturer
DuPont Nutrition USA, Inc
Hazard
  • specification-failure
  • out-of-spec-conductivity

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 (20)

  • Lot Numbers: P120834253
  • PN20834314
  • PN20834326
  • P220834329
  • P120834471
  • 2173728724
  • 2173731307
  • 2173739294
  • 2173742956
  • 2173743721
  • 2173747040 217374970
  • 2173749846
  • 2173751395
  • 2173751995
  • 2173753080
  • 2173749460
  • 2173755135
  • 2173755142
  • 2173758869
  • 22173758869 2173759101

Distribution

Distributed nationwide across the United States.