VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g)...
FDA Drug Recall #D-0151-2025 — Class II — November 22, 2024
Recall Summary
| Recall Number | D-0151-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 22, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Apothecus Pharmaceutical Corp. |
| Location | Hicksville, NY |
| Product Type | Drugs |
| Quantity | 33,659 retail boxes in US |
Product Description
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
Reason for Recall
CGMP deviations: out of specifications for assay
Distribution Pattern
Nationwide in the USA and 2 Distributors in Hong Kong
Lot / Code Information
Lot: 3A001/3A001A, Exp: 07/25
Other Recalls from Apothecus Pharmaceutical Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0427-2024 | Class II | VCF Vaginal Contraceptive Film (nonoxynol-9, 28... | Mar 21, 2024 |
| D-0623-2020 | Class III | VCF Vaginal Contraceptive Foam, a) can, 13 appl... | Nov 25, 2019 |
Frequently Asked Questions
cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.