CLASS III Drug recall · Reported 26 Sep 2018 · FDA Enforcement Report
Bupropion Hydrochloride ER Tablets, USP 150 mg recalled
InvaGen Pharmaceuticals is recalling Bupropion Hydrochloride ER Tablets, USP 150 mg, distributed nationwide in the US. The recall was initiated on 6 Sep 2018 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-1212-2018
- FDA event ID
- 80973
- Recalling firm
- InvaGen Pharmaceuticals, Hauppauge, NY
- Manufacturer
- CIPLA USA INC.,
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Sep 2018
- FDA classified
- 25 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 6 Sep 2018 | Recall initiated by company | |
| 25 Sep 2018 | Classified by FDA | +19 days |
| 26 Sep 2018 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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 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 was distributed
Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: a) 1612130, 1612131, Exp 11/18; 1709986, Exp 8/19; 1711549, Exp 10/19; b) 1701171, 1701174, 1701175, 1701176, Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19; 17110257, Exp 9/19; 1712809, 1801041, 1801051, Exp 12/19; 1802283, Exp 1/20
Where was it sold?
Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
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 26 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 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalled | 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 |
| Drug | CLASS II | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg recalledBupropion Hydrochloride | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | BuPROPion Hydrochloride Tablets, USP 75 mg (10 recalledBupropion Hydrochloride | Amerisource Health Services | Potency & Assay | Nationwide |