VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz… recall
FDA recall D-0151-2025 · initiated Nov 22, 2024
Apothecus Pharmaceutical Corp. recalled VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt… in Nov 2024 — an FDA Class II recall (D-0151-2025) because CGMP deviations: out of specifications for assay.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP deviations: out of specifications for assay
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 33,659 retail boxes in US
Details
- 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
- Recalling company
- Apothecus Pharmaceutical Corp.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and 2 Distributors in Hong Kong
- Initiated
- Nov 22, 2024
- FDA report date
- Dec 25, 2024
Frequently asked
- Was VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt… recalled?
- Apothecus Pharmaceutical Corp. recalled VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt… in Nov 2024 — an FDA Class II recall (D-0151-2025) because CGMP deviations: out of specifications for assay. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt… recalled?
- Per the FDA enforcement record, the reason for recall D-0151-2025 was: CGMP deviations: out of specifications for assay
- Is a recalled VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt… are affected?
- Distributed: Nationwide in the USA and 2 Distributors in Hong Kong. The recall covers these lots — Lot: 3A001/3A001A, Exp: 07/25. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0151-2025.