Fagron Recalls SyrSpend SF Suspending Base Due to Microbial Contamination
Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product was found to be contaminated with yeast and mold.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination with Aspergillus fumigatus, a pathogen capable of causing serious infections, particularly in immunocompromised individuals.
Plain-English summary
Fagron, Inc. is recalling SyrSpend SF Suspending Base, a prescription-only suspending base available in 500 mL and 4 L bottles. The recall involves 1,007 bottles of the 500 mL size and 738 bottles of the 4 L size. The affected products were distributed nationwide in the United States.
The recall was initiated due to microbial contamination. Testing revealed the presence of yeast and mold, specifically Paecilomyces saturatus and Aspergillus fumigatus. The agency has classified this as a Class II recall.
Consumers and healthcare providers should stop using the affected products and contact Fagron, Inc. or their healthcare provider for further instructions. The specific lot codes and expiration dates for the recalled items are listed in the official recall documentation.
The recalled product
- Product
- SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
- Manufacturer
- Fagron, Inc
- Category
- Drug — Pharmaceutical Excipient
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 (3)
- a) 17I28-U80-039976
- exp. 10/02/2020
- b) 17I28-U80-039977
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Fagron, Inc
See all →- HighNystatin Bulk Powder Recall for Incorrect Label Assay Value
FDA (Drugs) · 2023-12-27
- HighNystatin Powder Recall Due to Incorrect Assay Strength on Label
FDA (Drugs) · 2023-12-27
- HighNystatin bulk powder recall due to incorrect assay strength label
FDA (Drugs) · 2023-12-27
- HighNystatin Bulk Powder Recalled Due to Incorrect Label Strength
FDA (Drugs) · 2023-12-27
- SevereSyrSpend SF Suspending Base Recalled for Burkholderia Contamination
FDA (Drugs) · 2022-05-18
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateFagron Recalls SyrSpend SF Suspending Base Due to Yeast Contamination
FDA (Drugs) · 2016-02-17
- HighFagron Recalls SyrSpend SF Grape Flavor Due to Yeast Contamination
FDA (Drugs) · 2016-02-17
- ModerateFagron Recalls SyrSpend SF Syrup Due to Yeast Contamination
FDA (Drugs) · 2016-02-17
- SevereSyrSpend SF Suspending Base Recalled for Burkholderia Contamination
FDA (Drugs) · 2022-05-18
- SevereFagron Recalls Pentravan Base Due to Mold Contamination
FDA (Drugs) · 2014-08-06
- HighFagron Recalls Pentravan Plus Base Due to Mold Contamination
FDA (Drugs) · 2014-08-06