FDA Drugs recall ·
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators… recall
- Recall number
- D-0151-2025
- Date
- (initiated November 22, 2024)
- Company / brand
- Apothecus Pharmaceutical Corp.
485 S Broadway Ste 27, Hicksville, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 33,659 retail boxes in US
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
CGMP deviations: out of specifications for assay
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 3A001/3A001A, Exp: 07/25
Distribution
Nationwide in the USA and 2 Distributors in Hong Kong
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0151-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.