DuPont Recalls Avicel PH-101 Microcrystalline Cellulose for Out-of-Specification Conductivity
DuPont Nutrition USA is recalling specific batches of Avicel PH-101 NF microcrystalline cellulose due to failed conductivity specifications. The pharmaceutical excipient was distributed in bulk to manufacturers in the USA and multiple international locations.
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 recall with out-of-specification conductivity results on a pharmaceutical excipient. No reported illnesses or injuries. Specification failures represent quality deviations but are lower-risk than direct contamination with reported harm, per rubric guidance that Class III recalls are typically scored 1–2.
Plain-English summary
DuPont Nutrition USA, Inc. is recalling specific batches of Avicel PH-101 NF, a microcrystalline cellulose excipient used in pharmaceutical formulations. Approximately 464,050 kg of the product in bulk containers were affected.
The recall was initiated due to out-of-specification conductivity results for the affected batches. Conductivity specifications help ensure the purity and quality of the excipient.
The affected batches were distributed nationwide in the USA and internationally to Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Colombia. The specific batch numbers under recall are: 2173809472, 2173811313, P120834282, P120834305, P120834313, P120834324, P120834423, P120834437, P120834443, P120834478, 2173739298, 2173740020, 2173771315, P120834254, and P120834476.
The recalled product
- 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,
- Manufacturer
- DuPont Nutrition USA, Inc
- Category
- Drug — Pharmaceutical Excipient
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 Numbers: 2173809472
- 2173811313
- P120834282
- P120834305
- P120834313
- P120834324
- P120834423
- P120834437
- P120834443
- P120834478
- 2173739298
- 2173740020
- 2173771315
- P120834254
- P120834476
Distribution
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 →Related recalls
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