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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/Over-the-Counter

VCF Vaginal Contraceptive Gel Recalled for Potency Issues

Agency Publication Date: December 17, 2024
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Summary

Apothecus Pharmaceutical Corp. is recalling 33,659 retail boxes of VCF (Vaginal Contraceptive Gel) birth control due to manufacturing deviations that caused the product to fall outside of potency specifications. The recall affects 10-count boxes of pre-filled applicators with lot numbers 3A001 and 3A001A and an expiration date of July 2025. This defect means the active ingredient may not be at the correct concentration, which could affect how well the product works.

Risk

The gel failed potency testing, which means it may not contain the intended amount of active ingredient required for effective birth control. This defect could result in a higher risk of unintended pregnancy.

What You Should Do

  1. This recall affects VCF Vaginal Contraceptive Gel sold in boxes of 10 pre-filled applicators (0.09 oz each) with NDC 52925-512-10, specifically lot numbers 3A001 or 3A001A and an expiration date of 07/25.
  2. If you have health concerns or questions about alternative birth control methods, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Apothecus Pharmaceutical Corp. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

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: VCF Vaginal Contraceptive Gel (0.09 oz)
Variants: 10 Pre-filled Applicators, Birth Control
Lot Numbers:
3A001 (Exp 07/25)
3A001A (Exp 07/25)
NDC:
52925-512-10

Distributed By Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95824
Status: Active
Manufacturer: Apothecus Pharmaceutical Corp.
Sold By: Retailers nationwide; Distributors in Hong Kong
Manufactured In: United States
Units Affected: 33,659 retail boxes in US
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.