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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Testosterone Cypionate Injection Recalled for Impurities

Agency Publication Date: June 21, 2022
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Summary

Sun Pharmaceutical Industries Inc. is recalling 97,450 vials of Testosterone Cypionate (testosterone cypionate) Injection because manufacturing issues may have caused the drug to contain impurities. The recall affects 200 mg/mL strength vials sold in single-dose 1 mL cartons. While no injuries or illnesses have been reported, the medication may be out of specification for safety standards. Consumers who have this product should contact their healthcare provider or pharmacist for guidance.

Risk

The injection may contain impurities stemming from problematic manufacturing ingredients, which could lead to unexpected health reactions or reduced effectiveness of the hormone therapy.

What You Should Do

  1. The recalled products are 1 mL single-dose vials of Testosterone Cypionate Injection, USP (200 mg/mL) labeled with NDC 62756-015-40. This affects lot numbers HAC1974A and HAC1978A, both with an expiration date of 06/2023.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc. for further instructions.
  4. For disposal, a DEA medicine take-back location or pharmacy mail-back program is the preferred method for getting rid of unused prescription medication.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or want to report an adverse event.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Testosterone Cypionate Injection, USP (1 mL Single-dose vial)by Sun Pharmaceutical Industries Inc.
Variants: 200 mg/mL, Rx Only
Lot Numbers:
HAC1974A (Exp 06/2023)
HAC1978A (Exp 06/2023)
NDC:
62756-015-40

Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ; Manufactured by Sun Pharmaceutical Industries Ltd., India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90361
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: India
Units Affected: 97,450 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.