CLASS III Drug recall · Reported 7 Oct 2020 · FDA Enforcement Report
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg recalled
P & L Developments is recalling Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine) pieces per, distributed nationwide in the US. The recall was initiated on 9 Sep 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0004-2021
- FDA event ID
- 86403
- Recalling firm
- P & L Developments, Westbury, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Sep 2020
- FDA classified
- 1 Oct 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 9 Sep 2020 | Recall initiated by company | |
| 1 Oct 2020 | Classified by FDA | +22 days |
| 7 Oct 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
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.
Stores named: Rite Aid
Questions about this recall
Is Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine) pieces per recalled?
Yes. P & L Developments recalled Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine) pieces per on 9 Sep 2020. The recall is Class III and its status is Terminated. Recall number D-0004-2021.
Why was it 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.
Which lots are affected?
Lot # WJ04186, exp. date 01/23
Where was it sold?
Recalled product was distributed to one retailer type in NY and MD who may have further distributed the product throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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