The Recall Desk
ModerateFDA (Drugs)·D-0350-2023·Announced 2023-03-08

DuPont Avicel PH-102 Microcrystalline Cellulose Recalled for Conductivity Specification Failure

DuPont Nutrition USA is recalling Avicel PH-102 NF microcrystalline cellulose excipient due to failed conductivity specifications indicating potential impurities. 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: FDA Class III classification with no reported illnesses or injuries; the recall is precautionary based on a specification failure (conductivity) indicating potential impurities rather than confirmed harm.

Plain-English summary

DuPont Nutrition USA, Inc. is recalling Avicel PH-102 NF, a microcrystalline cellulose excipient used in pharmaceutical and other applications.

Test results showed that certain batches of this product failed to meet specifications for conductivity, which may indicate the presence of impurities or product degradation. The FDA has classified this as a Class III recall.

Approximately 368,980 kilograms of product in polyethylene-lined fiber drums, boxes, and sacks have been distributed. Distribution included the United States, Puerto Rico, Australia, China, Canada, Colombia, Mexico, Brazil, Malaysia, Chile, Dominican Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, and India. Specific batch numbers affected have been identified by the manufacturer.

Customers and pharmaceutical manufacturers who received this excipient should verify their lot numbers against the list provided by DuPont and contact the manufacturer for guidance on affected batches. The FDA continues to monitor this recall.

The recalled product

Product
Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, 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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Cope
Manufacturer
DuPont Nutrition USA, Inc
Category
Drug — Pharmaceutical Excipient
Hazard

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 (16)

  • Batch # 2173747038
  • 2173773188
  • 2173777535
  • P220834401
  • P220834402
  • P220834404
  • P220834406
  • P220834422
  • P220834425
  • P220834429
  • P220834430
  • P220834482
  • P220834505
  • P220834508
  • P220834543
  • These excipients are noted not to have an expiration date.

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 →

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