FDA recalls Avicel PH-102 microcrystalline cellulose bulk ingredient for specification failure
DuPont Nutrition is recalling Avicel PH-102 microcrystalline cellulose due to conductivity specification failures in 14 batches distributed across the USA and internationally.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall with no reported illnesses, injuries, or deaths. The hazard is a manufacturing specification failure without documented harm, consistent with low-severity classification.
Plain-English summary
DuPont Nutrition USA, Inc. is recalling Avicel PH-102 NF microcrystalline cellulose in bulk containers (20.0 kg net weight) because laboratory testing found the product did not meet conductivity specifications.
The affected product comprises approximately 320,350 kilograms distributed in bulk drums, boxes, and sacks across the United States and 15 other countries including Canada, Mexico, China, Australia, Spain, Saudi Arabia, and others. The recall involves 14 specific batch numbers manufactured by DuPont Nutrition USA, Inc.
Avicel PH-102 is a pharmaceutical excipient used as an ingredient in drug manufacturing. Manufacturers and distributors who obtained affected batches should discontinue use and contact DuPont Nutrition for recall instructions and disposition.
Consumers with questions about their medications should consult their pharmacist or healthcare provider.
The recalled product
- Product
- Avicel PH-102 NF, Microcrystalline Cellulose NF, 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,
- 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 (14)
- Batch Numbers: P220834360
- P220834366
- P220834383
- P220834440
- P220834460
- 2173755143
- 2173771316
- 2173773188
- P220834401
- P220834403
- P220834482
- P220834505
- P220834543
- P220834545
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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