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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Arbor Pharmaceuticals Inc.: Testosterone Cypionate Injection Recalled for Labeling Mix-up

Agency Publication Date: October 25, 2019
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Summary

Arbor Pharmaceuticals is recalling approximately 67,934 units of Testosterone Cypionate Injection, USP (2000 mg/10 mL, 1 mL Vial). The recall was initiated because the inner shelf cartons were incorrectly labeled as "10 mL multi-dose vials" when they actually contain "1 mL single-dose vials." This mismatch between the carton label and the actual contents could lead to confusion regarding the dosage or usage instructions. The medication was manufactured for Wilshire Pharmaceuticals and distributed nationwide.

Risk

The labeling error could cause a patient or healthcare provider to misinterpret the volume and dosage of the medication. Because the carton says 10 mL but only contains 1 mL vials, there is a risk of confusion about the quantity of medication available.

What You Should Do

  1. Check your prescription packaging for Testosterone Cypionate Injection, USP (NDC 52536-625-01) manufactured for Wilshire Pharmaceuticals.
  2. Identify if you have lot number 23803.002B with an expiration date of 07/2020, or lot number 23803.005A with an expiration date of 01/2021.
  3. Check if your shelf carton is labeled as a '10 mL multi-dose vial' despite containing 1 mL single-dose vials.
  4. Contact your healthcare provider or pharmacist for guidance on using this medication and to report the labeling discrepancy.
  5. Return any unused, affected product to the pharmacy or place of purchase for a refund and contact Arbor Pharmaceuticals for further instructions.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Testosterone Cypionate Injection, USP (2000 mg/10 mL, 1 mL Vial)
Model:
NDC 52536-625-01
Lot Numbers:
23803.002B (Exp 07/2020)
23803.005A (Exp 01/2021)
23803
Date Ranges: Exp 07/2020, Exp 01/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83959
Status: Resolved
Manufacturer: Arbor Pharmaceuticals Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 67934 units
Distributed To: Nationwide
Agency Last Updated: October 30, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.