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Bupropion Hydrochloride
Bupropion Hydrochloride recalls: 18 FDA reports
Recalls involving Bupropion Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.
18Reports
0Class I
3Ongoing
2025-10-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti
D-0037-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Failed Tablet/Capsule Specifications
- Product
- Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
- Where it went
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- How much
- 46,512/30 count bottles
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton
D-0590-2024 · Class II · reported 2024-07-17 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
- Product
- buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
- Where it went
- Nationwide in the USA
- How much
- 2,484 cartons
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for:
D-0222-2024 · Class II · reported 2024-01-17 · Ongoing
- Why it was recalled
- Presence of Foreign Tablets/Capsules
- Product
- buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
- Where it went
- Nationwide within the United States
- How much
- 47,976 bottles
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Phar
D-0137-2024 · Class III · reported 2023-12-13 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
- Where it went
- Nationwide
- How much
- 2016 Bottles
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by:
D-0044-2024 · Class III · reported 2023-10-25 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, 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, NDC 47335-737-86
- Where it went
- Nationwide in the USA.
- How much
- 144 bottles
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun P
D-0761-2023 · Class II · reported 2023-05-31 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; during stability testing
- Product
- buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
- Where it went
- Nationwide in the U.S.A
- How much
- 5,344 Bottles
BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: America
D-0328-2023 · Class II · reported 2023-02-22 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11
- Where it went
- Nationwide within the USA
- How much
- 1,416 cartons
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Su
D-0858-2022 · Class III · reported 2022-05-18 · Terminated
- Why it was 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.
- Product
- buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, 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, NDC 47335-738-86
- Where it went
- Nationwide in the USA
- How much
- 744 bottles
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86
D-0857-2022 · Class III · reported 2022-05-18 · Terminated
- Why it was 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.
- Product
- 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 went
- Nationwide in the USA
- How much
- 9804 bottles
bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pha
D-0489-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724
- Where it went
- FL, GA, SC
- How much
- 32 bottles
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufacture
D-1212-2018 · Class III · reported 2018-09-26 · Terminated
- Why it was recalled
- Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
- Product
- Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
- Where it went
- Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
- How much
- 26,496 bottles
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (
D-0619-2018 · Class III · reported 2018-04-11 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; during stability testing
- Product
- buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
- Where it went
- Nationwide
- How much
- N/A
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla
D-0618-2018 · Class III · reported 2018-04-11 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; during stability testing
- Product
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
- Where it went
- Nationwide
- How much
- N/A
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 4733
D-0445-2017 · Class III · reported 2017-02-01 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; 18 month stability time point
- Product
- 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
- Where it went
- Nationwide
- How much
- a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only,
D-0007-2017 · Class III · reported 2016-10-12 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
- Where it went
- Nationwide
- How much
- 31,762 bottles
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmac
D-1446-2016 · Class III · reported 2016-07-27 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
- Where it went
- Nationwide
- How much
- 16,085 bottles
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Di
D-1345-2015 · Class III · reported 2015-08-26 · Terminated
- Why it was 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.
- Product
- 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 went
- Nationwide and Puerto Rico
- How much
- 35,235 bottles
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b)
D-1043-2014 · Class III · reported 2014-02-05 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
- Product
- BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
- Where it went
- Nationwide and Puerto Rico
- How much
- 139,944 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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