FDA Recall D-0151-2025
Apothecus Pharmaceutical Corp. · Hicksville, NY
Class II Ongoing 538 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
CGMP deviations: out of specifications for assay
Recall record
- Recall number
D-0151-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA and 2 Distributors in Hong Kong
- Recall initiated
- 2024-11-22
- Classified by FDA Center
- 2024-12-17
- FDA published
- 2024-12-25
- Recalling firm
- Apothecus Pharmaceutical Corp.
- Firm location
- Hicksville, NY
Drug identification
- Brand name(s)
- VCF CONTRACEPTIVE PRE-FILLED APPLICATORS
- Generic name(s)
- NONOXYNOL-9
- Manufacturer(s)
- APOTHECUS PHARMACEUTICAL CORP
- NDC(s)
52925-512- Route(s)
- VAGINAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.