CLASS I Drug recall · Reported 18 Aug 2021 · FDA Enforcement Report

C-progesterone OIL 100 MG/ML vials, Compound recalled

People's Custom Rx and Clinical Care is recalling C-progesterone OIL 100 MG/ML vials, Compound, People's Custom Rx, Compounded, distributed in Mississippi, Tennessee. The recall was initiated on 11 May 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot: 11649 BUD: 07/07/2021
Quantity recalled14 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0718-2021
FDA event ID
88340
Recalling firm
People's Custom Rx and Clinical Care, Memphis, TN
Classification
Class I
Status
Terminated
Recall initiated
11 May 2021
FDA classified
9 Aug 2021
Reported
18 Aug 2021
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

11 May 2021Recall initiated by company
9 Aug 2021Classified by FDA+90 days
18 Aug 2021Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Non-Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117

Where it was distributed

MS, TN

MississippiTennessee

Questions about this recall

Is C-progesterone OIL 100 MG/ML vials, Compound, People's Custom Rx, Compounded recalled?

Yes. People's Custom Rx and Clinical Care recalled C-progesterone OIL 100 MG/ML vials, Compound, People's Custom Rx, Compounded on 11 May 2021. The recall is Class I and its status is Terminated. Recall number D-0718-2021.

Why was it recalled?

Non-Sterility

Which lots are affected?

Lot: 11649 BUD: 07/07/2021

Where was it sold?

MS, TN

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.