Food, drugs, devices › Apothecus Pharmaceutical Corp.
Drug recall: VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By:
FDA enforcement event 95824 is a drug recall by Apothecus Pharmaceutical Corp. of Hicksville, NY, initiated 22 Nov 2024 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 71% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Apothecus Pharmaceutical Corp. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Apothecus Pharmaceutical Corp., Hicksville, NY.
Reason for recall
"CGMP deviations: out of specifications for assay"
Distribution
"Nationwide in the USA and 2 Distributors in Hong Kong"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0151-2025 | 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 | 33,659 retail boxes in US | Class II | Ongoing | 25 Dec 2024 |
Context
Other enforcement events for Apothecus Pharmaceutical Corp.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Mar 2024 | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Ph | Drug | Class II | 1 |
| 25 Nov 2019 | VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack wi | Drug | Class III | 1 |
All 3 events for Apothecus Pharmaceutical Corp.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP deviations: out of specifications for assay"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA and 2 Distributors in Hong Kong"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.