Z-1953-2015Class II

Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant

Name: Z-1953-2015 Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant
Creator: Sheffield Pharmaceuticals, LLC
Published: 2015-04-27
License: https://open.fda.gov/license/

Sheffield Pharmaceuticals LLC / initiated 2015-04-27 / Terminated / root cause: manufacturing process

FDA source

Sheffield Pharmaceuticals, LLC began a recall of Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant on 2015-04-27. FDA classified it as Class II and gives the reason as "Recovery of high count of gram positive rods including single colonies of B. cepacia". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1953-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-27
Posted: 2015-07-02
Terminated: 2016-06-10
Recalling firm: Sheffield Pharmaceuticals LLC
Product: Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Product code: MMS Lubricant, Vaginal, Patient
Reason for recall: Recovery of high count of gram positive rods including single colonies of B. cepacia.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A letter was sent to inform customers of the voluntary recall of Sheffield Pharmaceuticals Lubri-Gel Personal Lubricant Jelly. The letter described the issue and asked customers to quarantine all related inventory immediately and provide their inventory counts on the specific lots. Questions or concerns related to the recall or letter can be directed to James Turner at [email protected].
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1953-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1953-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code MMS

K073684Class ISheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria , Ltd. / cleared 2008-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)