What does Class III mean?

Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.

Is this recall still active?

The FDA lists the recall as terminated (closed 01/21/2022). FDA has determined the recall is complete and closed it.

Checked Oct 26, 2026

Class IIIDrug recallTerminated

Nicotine Gum recall

Recalled by P & L Developments, LLC of Westbury, NY · FDA report 10/07/2020

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class III; Low risk
Status: Terminated; Closed 01/21/2022
Recall started: 09/09/2020
Distribution: Nationwide

Reason for recall

Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.

Class III: Use of or exposure to the product is not likely to cause adverse health consequences.

Recalled product

Product: Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
Lot and code info: Lot # WJ04186, exp. date 01/23
Quantity: 4,752 cartons
Recall number: D-0004-2021
Event ID: 86403
Initiated by: Voluntary: Firm initiated

Where it was distributed

Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.

Nationwide
Maryland
New York

Recall timeline

09/09/2020Firm started the recall
10/01/2020FDA classified it as Class III
10/07/2020Published in the FDA enforcement report
01/21/2022FDA closed (terminated) the recall

More recalls from P & L Developments

Class IIDrug06/26/2019Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape...P & L Developments, LLC · 3 products · cGMP Deviations: Firm was notified by their supplier of Cetirizine...

Frequently asked questions

Why was Nicotine Gum recalled?: Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
What does Class III mean?: Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.
Where was the recalled product sold?: Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
Is this recall still active?: The FDA lists the recall as terminated (closed 01/21/2022). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 10/07/2020 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class III
Status: Terminated
Type: Drug
Reported: 10/07/2020

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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