FDA Recalls VCF Contraceptive Film Due to Manufacturing Process Violations
The FDA is recalling VCF Contraceptive Film due to manufacturing process deviations. Apothecus Pharmaceutical Corp. initiated the voluntary recall on March 21, 2024, affecting 17,280 cartons distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall due to manufacturing process deviations with no reported illnesses or injuries. The hazard is based on compliance violations rather than confirmed product defects, consistent with a voluntary precautionary recall.
Plain-English summary
VCF Vaginal Contraceptive Film is a nonoxynol-9 (28%) vaginal contraceptive film product packaged as single films in cartons containing 9 films. The product is manufactured and distributed by Apothecus Pharmaceutical Corp., based in Ronkonkoma, New York.
The FDA issued a Class II recall due to current Good Manufacturing Practice (cGMP) deviations. The manufacturer voluntarily initiated the recall on March 21, 2024, following FDA center classification on March 28, 2024. The recall affects lot number 1G008A/1G00804722 with an expiration date of July 31, 2025.
Approximately 17,280 paper cartons were distributed nationwide. The manufacturer corrected the manufacturing process deviations, and the FDA terminated the recall on September 9, 2024.
Consumers who have product from the recalled lot should verify the lot number on their package. Those with questions about the recall may contact Apothecus Pharmaceutical Corp. or consult a healthcare provider.
The recalled product
- Product
- VCF CONTRACEPTIVE (NONOXYNOL-9)
- Brand
- VCF CONTRACEPTIVE
- Manufacturer
- Apothecus Pharmaceutical Corp.
- Category
- Drug — Contraceptive
- Hazard
- Affected units
- 17,280
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 # 1G008A/1G00804722
- Exp 07/31/25
Distribution
Distributed nationwide across the United States.
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