Drug recall: Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2),

FDA enforcement event 77060 · Class II · initiated 6 Apr 2017 · status Terminated · terminated 1 Jul 2019

DrugVoluntary: Firm initiated2 product recordsSaint Paul, MN

FDA enforcement event 77060 is a drug recall by Fagron, Inc of Saint Paul, MN, initiated 6 Apr 2017 and classified Class II, with 2 product records.

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. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 1 Jul 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

"cGMP Deviations: lack of quality assurance at the API manufacturer."

Distribution

"Nationwide in US and PR and Australia"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0791-2017	Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol…	15283 grams	Class II	Terminated	31 May 2017
D-0792-2017	Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone…	1313 grams	Class II	Terminated	31 May 2017

Context

57%of 2017 drug events are Class II343 events that year

2product records 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
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
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: "cGMP Deviations: lack of quality assurance at the API manufacturer."

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 in US and PR and Australia"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 1 Jul 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.