CLASS III Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Avicel, Mirocrystalline cellulose recalled by DuPont Nutrition USA
DuPont Nutrition USA is recalling Avicel, Mirocrystalline cellulose, distributed nationwide in the US. The recall was initiated on 5 Aug 2021 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-0728-2021
- FDA event ID
- 88428
- Recalling firm
- DuPont Nutrition USA, Newark, DE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Aug 2021
- FDA classified
- 16 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Aug 2021 | Recall initiated by company | |
| 16 Aug 2021 | Classified by FDA | +11 days |
| 25 Aug 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification results 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, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Where it was distributed
Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.
Questions about this recall
Is Avicel, Mirocrystalline cellulose recalled?
Yes. DuPont Nutrition USA recalled Avicel, Mirocrystalline cellulose on 5 Aug 2021. The recall is Class III and its status is Terminated. Recall number D-0728-2021.
Why was it recalled?
Out of specification results for conductivity.
Which lots are affected?
Lot Numbers: P120834253, PN20834314, PN20834326, P220834329, P120834471, 2173728724, 2173731307, 2173739294, 2173742956, 2173743721, 2173747040 217374970, 2173749846, 2173751395, 2173751995, 2173753080, 2173749460, 2173755135, 2173755142, 2173758869, 22173758869 2173759101, 2173759087, 2173760958, 21737606959, 2173762248, 217376233, 2173763871 2173763872, 2173755139, 2173763875, 2173764734, 2173763870, 2173764735, 2173769670, 2173775381, 2173776518, 217377536, 2173779284, 2173800414, 2173801736, 2173801737, 2173802516, 2173805796, 2173805797, 2173806449, 2173806450, 2173809474, 2173809473 2173810873, 2173811314, 2173811315, 2173806441, 217381169, 2173811666 These excipients are noted not to have an expiration date.
Where was it sold?
Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 recalled | DuPont Nutrition USA | Potency & Assay | Nationwide |