CLASS III Drug recall · Reported 18 May 2022 · FDA Enforcement Report
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg recalled
Sun Pharmaceutical Industries is recalling buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg, distributed nationwide in the US. The recall was initiated on 29 Apr 2022 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-0857-2022
- FDA event ID
- 90088
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Apr 2022
- FDA classified
- 10 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antidepressants
Timeline
| 29 Apr 2022 | Recall initiated by company | |
| 10 May 2022 | Classified by FDA | +11 days |
| 18 May 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
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
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India
Where it was distributed
Nationwide in the USA
Questions about this recall
Is buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg recalled?
Yes. Sun Pharmaceutical Industries recalled buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg on 29 Apr 2022. The recall is Class III and its status is Terminated. Recall number D-0857-2022.
Why was it recalled?
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Which lots are affected?
Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;
Where was it sold?
Nationwide in the USA
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.
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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 |