Drug recall: SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 515

FDA enforcement event 89805 · Class I · initiated 4 Mar 2022 · status Completed

DrugVoluntary: Firm initiated1 product recordSaint Paul, MN

FDA enforcement event 89805 is a drug recall by Fagron, Inc of Saint Paul, MN, initiated 4 Mar 2022 and classified Class I, with 1 product record.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Completed. 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 is contaminated with Burkholderia gladioli."

Distribution

"Nationwide USA and Puerto Rico, Canada, Columbia, France"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0856-2022	SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.	a) 559 bottles and b) 243 bottles	Class I	Completed	18 May 2022

Context

18%of 2022 drug events are Class I325 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
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
14 Feb 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	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 is contaminated with Burkholderia gladioli."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide USA and Puerto Rico, Canada, Columbia, France"

Is the recall still ongoing?

FDA lists the status as Completed. "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.