Fentanyl buccal tablets recalled due to incorrect or missing package insert
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall due to a documentation issue (missing or incorrect package insert) with no reported illnesses, injuries, or deaths. Per the rubric, documentation issues are classified as Level 1 (Low).
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling specific lots of Fentanyl Buccal Tablets CII, 800mcg. The product is packaged in cartons of 28 buccal tablets (4 tablets per card, 7 cards per carton). The affected lot numbers are 42617832 (expiration 06/2023), 42619530 (expiration 08/2023), and 100020532 (expiration 11/2024).
The recall is due to incorrect or missing package inserts. The package insert provides critical information necessary for the safe and proper use of the medication.
A total of 3,032 units were distributed nationwide under Rx-only status. The product was distributed by Mayne Pharma in Greenville, NC.
Patients and healthcare providers in possession of affected lots should consult with their pharmacist or healthcare provider regarding this recall.
The recalled product
- Product
- Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Opioid
- Hazard
- Affected units
- 3,032
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot#: 42617832
- Exp 06/2023
- 42619530
- Exp 08/2023
- 100020532
- Exp 11/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Teva Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Teva Pharmaceuticals USA Inc
See all →- ModerateTeva Recalls Metoclopramide Tablets Due to Foreign Object Presence
FDA (Drugs) · 2026-10-21
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- HighTeva isotretinoin 30 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
Same hazard · labeling error
See all →- ModerateLiquid Hope Organic Meal Replacement Formula Subpotent Vitamin A Recall
FDA (Food) · 2026-07-22
- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- Moderate
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighAdndale magnesium glycinate gummies contain undeclared melatonin in three lots
FDA (Food) · 2026-06-24
Similar recalls
- LowTeva Recalls Fentanyl Patches Due to Impurity Exceeding Limits
FDA (Drugs) · 2018-02-14
- ModerateTeva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits
FDA (Drugs) · 2018-02-14
- ModerateTeva Recalls Seasonale Tablets Due to Impurity Detection
FDA (Drugs) · 2013-06-05
- ModerateTeva Recalls Fentanyl Transdermal Systems Due to Impurity Levels
FDA (Drugs) · 2018-02-14
- LowTeva Recalls Tramadol Tablets Due to Incorrect Package Insert Labeling
FDA (Drugs) · 2020-02-26
- ModerateTeva Recalls Amethyst Oral Contraceptive Tablets Due to Incorrect Labeling
FDA (Drugs) · 2017-12-27