CLASS I Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF recalled
DuPont Nutrition USA is recalling Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder drum, distributed nationwide in the US. The recall was initiated on 27 Aug 2021 and the FDA has classified it as Class I.
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-0830-2021
- FDA event ID
- 88617
- Recalling firm
- DuPont Nutrition USA, Newark, DE
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Aug 2021
- FDA classified
- 23 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 27 Aug 2021 | Recall initiated by company | |
| 23 Sep 2021 | Classified by FDA | +27 days |
| 29 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Where it was distributed
Product was distributed to one account that may have used it as a component in finished drug formulations, and further distributed Nationwide in the USA.
Questions about this recall
Is Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder drum recalled?
Yes. DuPont Nutrition USA recalled Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder drum on 27 Aug 2021. The recall is Class I and its status is Terminated. Recall number D-0830-2021.
Why was it recalled?
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Which lots are affected?
Lot # 2173766940
Where was it sold?
Product was distributed to one account that may have used it as a component in finished drug formulations, and further distributed Nationwide in the USA.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 |