RecallRadar

FDA Device recall Z-1953-2015

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

On 2015-07-08 the FDA classified a Class II recall of Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant by Sheffield Pharmaceuticals, citing recovery of high count of gram positive rods including single colonies of B. cepacia.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1953-2015
ClassificationClass II
Statusterminated
Initiated2015-04-27
Published2015-07-08
Last updated2026-09-13 11:53 UTC
CompanySheffield Pharmaceuticals
DistributionCA, FL, GA, IL, KS, MI, MN, NC, NJ, NY, PR

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1953-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.