CLASS III Drug recall · Reported 31 May 2023 · FDA Enforcement Report
Fentanyl Buccal Tablets CII, 600mcg recalled by Teva Pharmaceuticals USA
Teva Pharmaceuticals USA is recalling Fentanyl Buccal Tablets CII, 600mcg, distributed nationwide in the US. The recall was initiated on 27 Apr 2023 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-0769-2023
- FDA event ID
- 92133
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Apr 2023
- FDA classified
- 24 May 2023
- Reported
- 31 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 27 Apr 2023 | Recall initiated by company | |
| 24 May 2023 | Classified by FDA | +27 days |
| 31 May 2023 | Published in enforcement report | +7 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
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
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
Where it was distributed
US Nationwide
Questions about this recall
Is Fentanyl Buccal Tablets CII, 600mcg recalled?
Yes. Teva Pharmaceuticals USA recalled Fentanyl Buccal Tablets CII, 600mcg on 27 Apr 2023. The recall is Class III and its status is Terminated. Recall number D-0769-2023.
Why was it recalled?
Labeling: Incorrect or Missing Package Insert
Which lots are affected?
Lot#: 42617831, Exp 06/2023; 42619585, Exp 11/2023; 100029649, Exp 11/2024
Where was it sold?
US Nationwide
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.
More recalls from Teva Pharmaceuticals USA
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Fentanyl buccal recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fentanyl Buccal Tablets CII, 100mcg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Fentanyl Buccal Tablets CII, 800mcg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Fentanyl Buccal Tablets CII, 200mcg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Fentanyl Buccal Tablets CII, 400mcg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |