CLASS II Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report

Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL recalled

Auro Pharmacies is recalling Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, distributed nationwide in the US. The recall was initiated on 21 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 180709/24, Exp 07-Sep-18

Quantity recalled11 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-1165-2018
FDA event ID: 80890
Recalling firm: Auro Pharmacies, La Habra, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 Aug 2018
FDA classified: 29 Aug 2018
Reported: 5 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

21 Aug 2018	Recall initiated by company
29 Aug 2018	Classified by FDA	+8 days
5 Sep 2018	Published in enforcement report	+7 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: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

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 Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Where it was distributed

Nationwide in USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Which lots are affected?

Lot #: 180709/24, Exp 07-Sep-18

Where was it sold?

Nationwide in USA

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

11 other products · FDA event 80890

This product is part of a recall event; the main page for the event is Methyl-Cobalamin injectable, 1 mg/mL recalled by Auro Pharmacies.

Reported	Class	Recall	Company	Reason	Where
5 Sep 2018	CLASS II	Methyl-Cobalamin injectable, 1 mg/mL recalled by Auro Pharmacies	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Methyl-Cobalamin injectable, 5 mg/mL Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Glutathione injectable, 200 mg/mL Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Dexpanthenol injectable, 250 mg/mL Single Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	CoEnzyme-Q10 injectable, 20 mg/mL Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Methyl-Cobalamin injectable, 2 mg/mL Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Folic Acid injectable, 10 mg/ml Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Methyl-Cobalamin injectable, 10 mg/mL Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018	CLASS II	Calcium Gluconate injectable, 10% Single Dose vial recalled	Auro Pharmacies	Sterility	Nationwide

More recalls from Auro Pharmacies

All 13

Reported	Class	Recall	Company	Reason	Where
17 Apr 2019Drug	CLASS III	Biotin 10 mg/mL Injection vial recalled by Auro Pharmacies	Auro Pharmacies	Other	Nationwide
5 Sep 2018Drug	CLASS II	Calcium Gluconate injectable, 10% Single Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018Drug	CLASS II	Methyl-Cobalamin injectable, 10 mg/mL Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018Drug	CLASS II	Folic Acid injectable, 10 mg/ml Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide
5 Sep 2018Drug	CLASS II	Methyl-Cobalamin injectable, 2 mg/mL Multiple Dose vial recalled	Auro Pharmacies	Sterility	Nationwide

Other Testosterone Enanthate recalls

All 4

Reported	Class	Recall	Company	Reason	Where
11 Jan 2017Drug	CLASS II	Testosterone Enanthate in Grapeseed Oil Injectable recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Testosterone Enanthate in Sesame Oil recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial recalled	The Compounding Pharmacy of America	Sterility	Nationwide