Auro Pharmacies Recalls Testosterone Cypionate/Enanthate Injectable Due to Sterility Concerns
Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
Auro Pharmacies, Inc. is recalling 32 vials of Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in 5 mL and 8 mL multiple-dose vials. The product was distributed nationwide in the USA. The specific lot number is 180606/18, with an expiration date of 30-Nov-18.
The recall was initiated due to a lack of assurance of sterility. The source text states that inadequate processes and equipment were used to assure the sterility of products intended to be sterile.
Consumers and healthcare providers should stop using the affected product and contact Auro Pharmacies, Inc. or their healthcare provider for further instructions.
The recalled product
- Product
- Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
- Manufacturer
- Auro Pharmacies, Inc.
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 180606/18
- Exp 30-Nov-18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Auro Pharmacies, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Auro Pharmacies, Inc.
See all →- SevereAuro Pharmacies Recalls Folic Acid Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
- SevereAuro Pharmacies Recalls Calcium Gluconate Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
- SevereAuro Pharmacies Recalls Testosterone Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
- SevereAuro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
- SevereAuro Pharmacies Recalls Testosterone Enanthate/Cypionate Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-09-05
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereTestosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
- HighTestosterone Cypionate Injectable Vials Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-20
- HighTestosterone Cypionate Injectable Vials Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-04-06
- SevereTestosterone Cypionate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Injection 200 mg/mL Recalled for Sterility Assurance
FDA (Drugs) · 2025-05-21
- SevereTestosterone Cypionate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2015-09-23