CLASS II Drug recall · Reported 22 Mar 2017 · FDA Enforcement Report
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg HDPE recalled
Teva Pharmaceuticals USA is recalling Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg HDPE, distributed nationwide in the US. The recall was initiated on 7 Feb 2017 and the FDA has classified it as Class II.
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-0517-2017
- FDA event ID
- 76432
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2017
- FDA classified
- 10 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Feb 2017 | Recall initiated by company | |
| 10 Mar 2017 | Classified by FDA | +31 days |
| 22 Mar 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot 30227056A; Exp. 03/17
Where was it sold?
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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
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|---|---|---|---|---|---|
| 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 Buprenorphine recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL recalled by Par Health USABuprenorphine Hydrochloride | Par Health USA | Other | Nationwide |
| Drug | CLASS II | Buprenorphine Hydrochloride, Injection, 0.3mg/mL recalled by Endo UsaBuprenorphine Hydrochloride | Endo USA | Other | Nationwide |
| Drug | CLASS II | Buprenorphine Hydrochloride Injection recalled by PfizerBuprenorphine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile ProductsBuprenorphine Hydrochloride | PAR Sterile Products | Packaging Defects | Nationwide |