CLASS III Drug recall · Reported 11 Apr 2018 · FDA Enforcement Report
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg recalled
InvaGen Pharmaceuticals is recalling buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, distributed nationwide in the US. The recall was initiated on 15 Mar 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-0618-2018
- FDA event ID
- 79446
- Recalling firm
- InvaGen Pharmaceuticals, Hauppauge, NY
- Manufacturer
- Cipla USA Inc.,
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Mar 2018
- FDA classified
- 4 Apr 2018
- Reported
- 11 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 15 Mar 2018 | Recall initiated by company | |
| 4 Apr 2018 | Classified by FDA | +20 days |
| 11 Apr 2018 | Published in enforcement report | +7 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 Specifications; during stability testing
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 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 was distributed
Nationwide
Questions about this recall
Is buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg recalled?
Yes. InvaGen Pharmaceuticals recalled buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg on 15 Mar 2018. The recall is Class III and its status is Terminated. Recall number D-0618-2018.
Why was it recalled?
Failed Dissolution Specifications; during stability testing
Which lots are affected?
Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
Where was it sold?
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 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 |