CLASS III Drug recall · Reported 26 Aug 2015 · FDA Enforcement Report
buPROPion Hydrochloride Extended-¿release Tablets USP (SR) recalled
Sun Pharma Global Fze is recalling buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, distributed nationwide in the US. The recall was initiated on 17 Jul 2015 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-1345-2015
- FDA event ID
- 71949
- Recalling firm
- Sun Pharma Global Fze, Sharm
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jul 2015
- FDA classified
- 14 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 17 Jul 2015 | Recall initiated by company | |
| 14 Aug 2015 | Classified by FDA | +28 days |
| 26 Aug 2015 | 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 Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting 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
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day recalled?
Yes. Sun Pharma Global Fze recalled buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day on 17 Jul 2015. The recall is Class III and its status is Terminated. Recall number D-1345-2015.
Why was it recalled?
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Which lots are affected?
Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
Where was it sold?
Nationwide and Puerto Rico
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 Sun Pharma Global Fze
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|---|---|---|---|---|---|
| Drug | CLASS II | Alendronate Sodium Tablets, USP, 70 mg* blisters recalled | Sun Pharma Global Fze | Potency & Assay | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled | Sun Pharma Global Fze | Particulate Matter | Nationwide |
| Drug | CLASS II | Levetiracetam, extended release tablets, 750 mg recalled | Sun Pharma Global Fze | Potency & Assay | Nationwide |
Other Bupropion recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalledBupropion Hydrochloride | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | buPROPion Hydrochloride Extended-release Tablets recalledBupropion Hydrochloride | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalledBupropion Hydrochloride | Rising Pharma Holding | Other | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg recalledBupropion Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg recalledBupropion Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |