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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 Film Recalled for Manufacturing Deviations

Agency Publication Date: March 28, 2024
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Summary

Apothecus Pharmaceutical Corp. is voluntarily recalling 17,280 paper cartons of VCF Vaginal Contraceptive Film (nonoxynol-9, 28%) due to deviations from Current Good Manufacturing Practice (cGMP) requirements. The recall affects 9-count cartons identified by NDC 52925-112-01. If you have used this product and have health concerns, you should contact your healthcare provider or pharmacist for medical advice.

Risk

Deviations in manufacturing practices mean the product may not meet safety and quality standards, which could potentially impact the effectiveness or safety of the contraceptive film.

What You Should Do

  1. The recalled products are 9-count cartons of VCF Vaginal Contraceptive Film (nonoxynol-9, 28%) distributed by Apothecus Pharmaceutical Corp. with NDC 52925-112-01.
  2. Identify the affected products by looking for Lot # 1G008A/1G00804722 with an expiration date of 07/31/25 printed on the packaging.
  3. If you have health concerns, contact your healthcare provider or pharmacist. 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) for additional questions.

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 Film (9 single films)
Variants: nonoxynol-9, 28%, Carton
Lot Numbers:
1G008A/1G00804722 (Exp 07/31/25)
1G008A
NDC:
52925-112-01

Recall #: D-0427-2024; Quantity: 17,280 paper cartons.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94277
Status: Resolved
Manufacturer: Apothecus Pharmaceutical Corp.
Manufactured In: United States
Units Affected: 17,280 paper cartons
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.