Class II — Sheffield Pharmaceuticals, LLC
| Recalling firm | Sheffield Pharmaceuticals LLC |
|---|---|
| Registered facility | Sheffield Pharmaceuticals LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Recovery of high count of gram positive rods including single colonies of B. cepacia. |
| Product | Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant. |
| Quantity | 37,636 pieces |
| Distribution | Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia. |
| Initiated | 2015-04-27 |
| Classified | 2015-07-02 |
| Terminated | 2016-06-10 |
| Recall number | Z-1953-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sheffield Pharmaceuticals, LLC (Z-1953-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71129/
Alerts for Sheffield Pharmaceuticals LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.