Drug recall: Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale,

FDA enforcement event 85839 · Class I · initiated 9 Jun 2020 · status Terminated · terminated 16 Oct 2023

DrugVoluntary: Firm initiated1 product recordSouth Richmond Hill, NY

MasterPharm LLC (South Richmond Hill, NY) initiated this drug recall on 9 Jun 2020; FDA lists 1 product record under event 85839, classified Class I.

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. 15% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 16 Oct 2023. Initiation: voluntary: firm initiated. MasterPharm LLC has 3 enforcement events on this register, with a median of 1 product record 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

MasterPharm LLC, South Richmond Hill, NY.

Reason for recall

"Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin."

Distribution

"FL and MD"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1363-2020	Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.	300 capsules	Class I	Terminated	8 Jul 2020

Context

15%of 2020 drug events are Class I342 events that year

1product record in this eventfirm median: 1

3events on this register for the firm

Other enforcement events for MasterPharm LLC

Initiated	Product (first record)	Type	Class	Records
2 Jul 2020	Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (86	Drug	Class II	26
14 Apr 2020	Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm	Drug	Class I	1

All 3 events for MasterPharm LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin."

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: "FL and MD"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Oct 2023. "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.