Facility

Reckitt Benckiser LLC

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

Key facts

4recalls · worst Class II

1inspections · 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)	3003979157
Establishment type	Repack or Relabel Medical Device
Location	360 Independence Avenue Harrisburg, PA, US 17102
Registration status	Active · expires 2026
Parent company	Reckitt Benckiser LLC (owner-operator 9004884)
Brand names	Durex Tropicals; Durex Intense Sensation

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

Condom
Product code HIS (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.5300

Recalls & enforcement

Class IITerminated2018-12-19
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
Class IITerminated2018-08-06
Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Class IITerminated2018-07-23
The products failed the filed specification of 1.0kPa for Burst Pressure.
Class IITerminated2016-11-22
Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.

FDA inspections (1)

VAI2016-05-12
Voluntary Action Indicated · Compliance: 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.

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. “Reckitt Benckiser LLC (FEI 3003979157) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003979157-reckitt-benckiser-llc/

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