DuPont Avicel DG pharmaceutical ingredient recalled for failed quality specification
DuPont Nutrition USA is recalling Avicel DG, a pharmaceutical ingredient, due to failed quality specifications. The product did not meet conductivity standards during manufacturing testing.
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. This is a voluntary precautionary recall due to failed quality specifications (conductivity testing), classified under the rubric as a low-risk contamination/precautionary category.
Plain-English summary
DuPont Nutrition USA, Inc. is recalling Avicel DG, a pharmaceutical ingredient consisting of microcrystalline cellulose and dibasic calcium phosphate. The product was distributed in bulk containers (20.0 kg net content) with the following batch numbers: 2213749659, 2213766837, 2213776558, and 2213776559.
The recall was issued due to failed impurities and degradation specifications. Specifically, out-of-specification results were obtained for conductivity testing during manufacturing quality control. The product did not meet established conductivity standards.
The recalled product was distributed nationwide in the USA as well as internationally to Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Colombia. Affected customers should contact DuPont Nutrition USA, Inc. for guidance on the affected batches and any necessary product disposition.
The recalled product
- Product
- Avicel DG, MCC/Dibasic Calcium Phosphate, 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; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenh
- Manufacturer
- DuPont Nutrition USA, Inc
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
- failed-quality-specification
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 (4)
- Batch Numbers: 2213749659
- 2213766837
- 2213776558
- 2213776559
Distribution
Distributed nationwide across the United States.
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