Class II · Moderate risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications
buPROPion Hydrochloride Extended-release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
Affected NDCs
47335-0737-13
47335-0737-86
47335-0737-88
Compare with the code on your package — it is the most precise check available.
Drug: Bupropion Category: Mental Health Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Bupropion hydrochloride NDC 47335-0737 |
150 mg/1 | Tablet, Film Coated, Extended Release Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- NDC code
- 47335-737-86
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0445-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bupropion recalls
See all
Class II · Moderate risk
buPROPion Hydrochloride Extended-release Tablets USP
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk
buPROPion Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Dissolution Specifications
Other recalls by Sun Pharmaceutical Industries, Inc.
All 2016 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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