Fentanyl Buccal Tablets recalled due to missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.
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 a Class III FDA recall for a documentation issue—missing or incorrect package inserts—with no reported harm or adverse events.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets CII 100mcg distributed nationwide. The recall affects 438 units across Lot Number 42617828 (expiration 06/2023) and Lot Number 100020465 (expiration 01/2024), packaged in cartons of 28 tablets.
The recall was issued because the affected packages contain incorrect or missing package inserts. Package inserts provide essential information about medication administration, dosing, and safety precautions.
Patients who have packages matching the recalled lot numbers should contact their pharmacy or healthcare provider to obtain the correct package insert or verify their package contains complete labeling information.
The recalled product
- Product
- Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 438
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 (4)
- Lot# 42617828
- Exp 06/2023
- 100020465
- Exp 01/2024
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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- LowTeva Recalls Fentanyl Patches Due to Impurity Exceeding Limits
FDA (Drugs) · 2018-02-14
- LowTeva Recalls Tramadol Tablets Due to Incorrect Package Insert Labeling
FDA (Drugs) · 2020-02-26
- 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 Famotidine Tablets Due to Weight Specification Failures
FDA (Drugs) · 2017-08-09
- LowTeva Recalls Nabumetone Tablets Due to Missing Labels and Leaflets
FDA (Drugs) · 2016-03-23