Sheffield Pharmaceuticals, LLC: Medical Device Recall in 2015 - (Recall #: Z-1953-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 27, 2015

Date Posted: July 8, 2015

Recall Number: Z-1953-2015

Event ID: 71129

Reason for Recall:

Recovery of high count of gram positive rods including single colonies of B. cepacia.

Status: Terminated

Product Quantity: 37,636 pieces

Code Information:

Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18

Distribution Pattern:

Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.

Voluntary or Mandated:

Voluntary: Firm initiated