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.
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 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, Cope
- Manufacturer
- DuPont Nutrition USA, Inc
- Category
- Drug — Pharmaceutical Excipient
- Hazard
- impurities
- degradation
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.
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