Teva Pharmaceuticals Buprenorphine and Naloxone Sublingual Recall

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

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

Lot numbers, UPCs & expiration codes

Lot 30227056A; Exp. 03/17

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0517-2017
Classification: Class II
Status: Terminated
Recall initiated: Feb 7, 2017
FDA report date: Mar 22, 2017
Quantity: 7,628 HDPE bottles (228,840 tablets)
Recall type: Voluntary: Firm initiated
Recalling firm: Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0517-2017, exactly as published.

Show all FDA fields

City: North Wales
State: PA
Status: Terminated
Country: United States
Event ID: 76432
Address: 1090 Horsham Rd
Code information: Lot 30227056A; Exp. 03/17
Postal code: 19454-1505
Report date: Mar 22, 2017
Product type: Drugs
Recall number: D-0517-2017
Classification: Class II
Recalling firm: Teva Pharmaceuticals USA
Product quantity: 7,628 HDPE bottles (228,840 tablets)
Termination date: Feb 16, 2018
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: Nationwide
Recall initiation date: Feb 7, 2017
Initial firm notification: Letter
Center classification date: Mar 10, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0517-2017, published Mar 22, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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