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Drug FDA Class II Ongoing Failed specifications

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

Apothecus Pharmaceutical Corp. Published Dec 25, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Apothecus Pharmaceutical Corp. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP deviations: out of specifications for assay

Hazards

Failed Assay Specification · primary

Affected products (1)

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

VCF CONTRACEPTIVE PRE-FILLED APPLICATORS · 33,659 retail boxes in US

NDC: 52925-512, 52925-512-10, 52925-512-25
Lot codes: 3A001
Code info: Lot: 3A001/3A001A, Exp: 07/25

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 22, 2024
  2. Published
    Dec 25, 2024
Recall number
D-0151-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.