VCF Vaginal Contraceptive Film (nonoxynol-9 recall
FDA recall D-0427-2024 · initiated Mar 21, 2024
Apothecus Pharmaceutical Corp. recalled VCF Vaginal Contraceptive Film (nonoxynol-9 in Mar 2024 — an FDA Class II recall (D-0427-2024) because cGMP Diviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Diviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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: 17,280 paper cartons
Details
- Product
- VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
- Recalling company
- Apothecus Pharmaceutical Corp.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Mar 21, 2024
- FDA report date
- Apr 3, 2024
Frequently asked
- Was VCF Vaginal Contraceptive Film (nonoxynol-9 recalled?
- Apothecus Pharmaceutical Corp. recalled VCF Vaginal Contraceptive Film (nonoxynol-9 in Mar 2024 — an FDA Class II recall (D-0427-2024) because cGMP Diviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was VCF Vaginal Contraceptive Film (nonoxynol-9 recalled?
- Per the FDA enforcement record, the reason for recall D-0427-2024 was: cGMP Diviations
- Is a recalled VCF Vaginal Contraceptive Film (nonoxynol-9 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 Film (nonoxynol-9 are affected?
- Distributed: USA nationwide.. The recall covers these lots — Lot # 1G008A/1G00804722, Exp 07/31/25. 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-0427-2024.