Nicotine Gum — Class III drug recall D-0004-2021
Terminated recall by P & L Developments, LLC, reported 2020-10-07, distributed nationwide. Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the
| Recall number | D-0004-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | P & L Developments, LLC, Westbury, NY, United States |
| Recall initiated | 2020-09-09 |
| Classified | 2020-10-01 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2022-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 4,752 cartons |
| Reason classes | labeling |
| NDC | 11822-3328-03 |
| Lot numbers | 01/23, WJ04186 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0004-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.