CLASS II ONGOING Drug recall · Reported 25 Dec 2024 · FDA Enforcement Report
VCF, Vaginal Contraceptive Gel, Birth Control recalled
Apothecus Pharmaceutical is recalling VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, distributed nationwide in the US. The recall was initiated on 22 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0151-2025
- FDA event ID
- 95824
- Recalling firm
- Apothecus Pharmaceutical, Hicksville, NY
- Manufacturer
- APOTHECUS PHARMACEUTICAL CORP
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2024
- FDA classified
- 17 Dec 2024
- Reported
- 25 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 22 Nov 2024 | Recall initiated by company | |
| 17 Dec 2024 | Classified by FDA | +25 days |
| 25 Dec 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: out of specifications for assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA and 2 Distributors in Hong Kong
Questions about this recall
Why was it recalled?
CGMP deviations: out of specifications for assay
Which lots are affected?
Lot: 3A001/3A001A, Exp: 07/25
Where was it sold?
Nationwide in the USA and 2 Distributors in Hong Kong
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apothecus Pharmaceutical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%) recalledVcf Contraceptive | Apothecus Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | VCF Vaginal Contraceptive Foam, a), 13 applications recalled | Apothecus Pharmaceutical | Packaging Defects | Nationwide |
Other Nonoxynol-9 recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%) recalledVcf Contraceptive | Apothecus Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |