CLASS III Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur. recalled
DuPont Nutrition USA is recalling Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight, distributed nationwide in the US. The recall was initiated on 1 Feb 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0349-2023
- FDA event ID
- 91616
- Recalling firm
- DuPont Nutrition USA, Newark, DE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Feb 2023
- FDA classified
- 24 Feb 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 1 Feb 2023 | Recall initiated by company | |
| 24 Feb 2023 | Classified by FDA | +23 days |
| 8 Mar 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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, Copenhagen, Denmark
Where it was distributed
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Which lots are affected?
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.
Where was it sold?
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 91616This product is part of a recall event; the main page for the event is BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. recalled | DuPont Nutrition USA | Potency & Assay | Nationwide | |
| CLASS III | Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur. recalled | DuPont Nutrition USA | Potency & Assay | Nationwide | |
| CLASS III | Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur. recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |
More recalls from DuPont Nutrition USA
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Avicel PH-101 NF, Microcrystalline Cellulose NF recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Avicel PH-102 NF, Microcrystalline Cellulose NF recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Avicel DG, MCC/Dibasic Calcium Phosphate recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Avicel PH-200 NF, Microcrystalline Cellulose NF recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur. recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |
Other Avicel Ph- 101 recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Avicel PH-101 NF, Microcrystalline Cellulose NF recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |