Facility

Sheffield Pharmaceuticals LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1210513
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	170 Broad St NEW LONDON, CT, US 06320
Registration status	Active · expires 2026
Parent company	Sheffield Pharmaceuticals LLC (owner-operator 1210513)
Brand names	Well at Walgreens Warming Jelly

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Lubricant, Personal
Product code NUC (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.5300

Recalls & enforcement

Class IITerminated2015-04-27
Recovery of high count of gram positive rods including single colonies of B. cepacia.

FDA inspections (2)

NAI2025-06-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-03-15
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Sheffield Pharmaceuticals LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Sheffield Pharmaceuticals LLC (FEI 1210513) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1210513-sheffield-pharmaceuticals-llc/

Not open yet

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.

Planned

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.