The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0349-2023·Announced 2023-03-08

Microcrystalline Cellulose Ingredient Recalled Over Failed Impurity Specifications

DuPont Nutrition USA, Inc. is recalling certain batches of Avicel PH-101 microcrystalline cellulose because it failed quality testing for impurities and degradation. The ingredient showed out-of-specification conductivity levels.

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: FDA Class III recall with no reported illnesses or injuries. The hazard is a specification failure with potential impurities rather than a confirmed contamination or adverse event, consistent with precautionary low-risk recalls.

Plain-English summary

DuPont Nutrition USA, Inc. is recalling 131,060 kg of Avicel PH-101 NF (microcrystalline cellulose) in polyethylene-lined containers. Microcrystalline cellulose is an ingredient used by pharmaceutical manufacturers in the production of drugs.

The recall was initiated because the product failed quality specification testing. The ingredient showed out-of-specification results for conductivity, indicating the presence of potential impurities or degradation products. This suggests the ingredient may not meet required purity standards.

The affected product batches are: 2173763874, 2173771315, P120834254, P120834263, P120834267, P120834275, P120834441, P120834442, P120834472, P120834507, P120834517, P120834518, P120834519, and P120834520. The product was distributed nationwide in the United States and Puerto Rico and to Australia, China, Canada, Colombia, Mexico, Brazil, Malaysia, Chile, Dominican Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, and India.

Pharmaceutical manufacturers and distributors who received this ingredient in the affected batches should stop using it and review whether any products they manufactured with this ingredient require recalls or precautionary recalls.

The recalled product

Product
Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. 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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1…
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 (15)

  • Batch # 2173763874
  • 2173771315
  • P120834254
  • P120834263
  • P120834267
  • P120834275
  • P120834441
  • P120834442
  • P120834472
  • P120834507
  • P120834517
  • P120834518
  • P120834519
  • P120834520
  • 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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