CLASS II Drug recall · Reported 17 Jul 2019 · FDA Enforcement Report

Testosterone Cypionate 200 mg/mL Sesame Oil Injection recalled

First Pharma Associates is recalling Testosterone Cypionate 200 mg/mL Sesame Oil Injection, distributed in Idaho, Washington. The recall was initiated on 26 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 05022019@31, Exp. 08/4/2019; 05152019@18, Exp. 08/13/2019; b) 05292019@4, Exp. 08/28/2019.

Quantity recalleda) 18 mL b) 12mL

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-1470-2019
FDA event ID: 83253
Recalling firm: First Pharma Associates, Spokane, WA
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2019
FDA classified: 11 Jul 2019
Reported: 17 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

26 Jun 2019	Recall initiated by company
11 Jul 2019	Classified by FDA	+15 days
17 Jul 2019	Published in enforcement report	+6 days

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

Reason for recall

Lack of Assurance of 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

Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252

Where it was distributed

ID, WA only

Idaho Washington

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility.

Which lots are affected?

Lot #: a) 05022019@31, Exp. 08/4/2019; 05152019@18, Exp. 08/13/2019; b) 05292019@4, Exp. 08/28/2019.

Where was it sold?

ID, WA only

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

17 other products · FDA event 83253

This product is part of a recall event; the main page for the event is PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection vial recalled.

Reported	Class	Recall	Company	Reason	Where
17 Jul 2019	CLASS II	PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Prostaglandin 20 mcg/mL/Procaine 0.1% Injection recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Methylcobalamin 10 mg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Testosterone Cypionate 100 mg/mLOil Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Testosterone Cypionate 150 mg/mL Sesame Oil Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Glutathione 100 mg/mL Inhalation Solution (PF) vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Testosterone Cypionate 100 mg/mL Sesame Oil Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Serum Tears 20% Eye Drops PF Solution recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Chorionic Gonadotropin 2,000U/mL PF Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Methylcobalamin 1 mg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019	CLASS II	Hydroxocobalamin 10 mg/mL Injection (ALT) Solution vial recalled	First Pharma Associates	Sterility	ID, WA

More recalls from First Pharma Associates

All 18

Reported	Class	Recall	Company	Reason	Where
17 Jul 2019Drug	CLASS II	Hydroxocobalamin 10 mg/mL Injection (ALT) Solution vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019Drug	CLASS II	Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019Drug	CLASS II	Methylcobalamin 1 mg/mL Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019Drug	CLASS II	Chorionic Gonadotropin 2,000U/mL PF Injection vial recalled	First Pharma Associates	Sterility	ID, WA
17 Jul 2019Drug	CLASS II	Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection recalled	First Pharma Associates	Sterility	ID, WA

Other Testosterone Cypionate recalls

All 130

Reported	Class	Recall	Company	Reason	Where
21 May 2025Drug	CLASS II	Testosterone Cypionate Injection, 200 mg/mL, CIII recalled	Empower Clinic Services	Sterility	Nationwide
23 Apr 2025Drug	CLASS II	Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate	Eugia US	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate	Azurity Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
20 Jul 2022Drug	CLASS II	Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled	TMC Acquisition	Sterility	Nationwide