P & L Developments Recalls Nicotine Gum Due to Labeling Errors
P & L Developments recalls Nicotine Gum 2 mg distributed by Rite Aid due to incorrect package inserts. Check your lot number and expiration date.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
P & L Developments, LLC is recalling Nicotine Polacrilex Gum USP, 2 mg because the package insert included in the finished product is for the Canadian market and does not match the current approved drug labeling. The recall affects approximately 4,752 cartons distributed to a retailer type in New York and Maryland. No remedy or action steps are currently stated in the record. Read more at govinfonow.com/recall/36782-p-l-developments-recalls-nicotine-gum-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/36782-p-l-developments-recalls-nicotine-gum-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0004-2021
Cite this page
“P & L Developments Recalls Nicotine Gum Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36782-p-l-developments-recalls-nicotine-gum-due-to-labeling-errors. Based on FDA recall #D-0004-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0004-2021%22&limit=1).
Why it’s dangerous
The hazard is that the included package insert contains information intended for the Canadian market rather than the approved U.S. labeling. This discrepancy means users may not have access to the correct dosage, safety, or regulatory information required for this specific product in the United States.
Who’s affected
Consumers who purchased Nicotine Gum from a retailer in New York or Maryland between distribution dates not specified here. Individuals relying on the package insert for accurate U.S.-specific usage instructions or warnings are at risk of using incorrect information.
How to tell if you have this one
Check if you have Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), in a 110-count piece carton distributed by Rite Aid. Look for NDC 11822-3328-3 and Lot # WJ04186 with an expiration date of 01/23.
- Brand
P & L Developments- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your nicotine gum matches the recalled NDC 11822-3328-3 and Lot # WJ04186 with an expiration date of 01/23.
Monitor for Updates
Since no remedy is currently stated, check the FDA recall database or contact Rite Aid for further instructions on how to proceed.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Maryland, New York.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0004-2021 (September 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0004-2021 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.