Drug recall: SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron

FDA enforcement event 79253 · Class II · initiated 14 Feb 2018 · status Terminated · terminated 10 Sep 2019

DrugVoluntary: Firm initiated1 product recordSaint Paul, MN

FDA enforcement event 79253 is a drug recall by Fagron, Inc of Saint Paul, MN, initiated 14 Feb 2018 and classified Class II, with 1 product record.

FDA defines Class II as 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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 10 Sep 2019. Initiation: voluntary: firm initiated. Fagron, Inc has 10 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Fagron, Inc, Saint Paul, MN.

Reason for recall

"Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus)."

Distribution

"Nationwide, USA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0547-2018	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	a) 1007 bottles (500 mL) and b) 738 bottles (4 L)	Class II	Terminated	7 Mar 2018

Context

60%of 2018 drug events are Class II367 events that year

1product record in this eventfirm median: 2

10events on this register for the firm

Other enforcement events for Fagron, Inc

Initiated	Product (first record)	Type	Class	Records
11 Dec 2023	NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc	Drug	Class II	4
4 Mar 2022	Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot K	Drug	Class III	5
4 Mar 2022	SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 515	Drug	Class I	1
31 Oct 2019	LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4	Drug	Class II	1
25 Oct 2017	Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2),	Drug	Class II	1
17 Apr 2017	Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-	Drug	Class III	1
6 Apr 2017	Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2),	Drug	Class II	2
11 Nov 2015	SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneo	Drug	Class II	3
24 Jul 2014	Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying o	Drug	Class II	3

All 10 events for Fagron, Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus)."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide, USA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Sep 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.