InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC
InvaGen Pharmaceuticals recalls 150mg buPROPion HCl Extended-Release Tablets due to failed dissolution testing during stability checks. These prescription pills (NDC 69097-878-03 and 69097-878-07) may not release medication properly.
Lower-risk recall
Failed Dissolution Specifications; during stability testing
Contact the company & request your remedy
What happened, in plain English
InvaGen Pharmaceuticals is recalling specific lots of buPROPion HCl Extended-Release Tablets because they failed dissolution testing during stability checks. This means the medication might not release properly as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/40778-invagen-bupropion-hcl-extended-release-tablets-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/40778-invagen-bupropion-hcl-extended-release-tablets-recall-failed-dissolution-testing · Updated October 7, 2026 · FDA enforcement record: FDA #D-0619-2018
Cite this page
“InvaGen buPROPion HCl Extended-Release Tablets Recall: Failed Dissolution Testing.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40778-invagen-bupropion-hcl-extended-release-tablets-recall-failed-dissolution-testing. Based on FDA recall #D-0619-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0619-2018%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing during stability checks, meaning they may not release medication properly over time. This could lead to inconsistent dosing and reduced effectiveness of the treatment. However, the recall does not indicate immediate safety risks like injury or death.
Who’s affected
Prescription users of the recalled buPROPion HCl Extended-Release Tablets (150 mg, 60-count and 100-count bottles) who received them between May 2018 and September 2018. People taking this medication for depression or weight management are most at risk.
How to tell if you have this one
Check for bottles labeled 'buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg' with NDC codes 69097-878-03 (60-count) or 69097-878-07 (100-count). These were manufactured for Cipla USA Inc. and sold between May 2018 and September 2018.
- Brand
InvaGen- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide- NDC
69097-877-02, 69097-877-03, 69097-877-07, 69097-877-12, 69097-878-02, 69097-878-03, 69097-878-07, 69097-878-12, 69097-879-02, 69097-879-03, 69097-879-07, 69097-879-12
| Recall number | Product, codes & lots |
|---|---|
| D-0618-2018 | 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; Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018 |
| D-0619-2018 | 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; a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018 |
What to do — step by step
Check Your Medication
Look for the NDC codes 69097-878-03 or 69097-878-07 on the bottle label to confirm if your medication is recalled.
Questions people ask
Why is this medication being recalled?
The tablets failed dissolution testing during stability checks, meaning they may not release medication properly as intended.
What should I do if I have the recalled medication?
Check the NDC codes on your bottle label to confirm if it's recalled. If it is, contact your doctor or pharmacist for guidance.
Are there any safety risks from using this medication?
The recall indicates potential treatment effectiveness issues but does not mention immediate safety risks like injury or death.
Contact InvaGen
We’ve drafted a message you can send InvaGen to request your refund or repair — edit it as you like.
Subject: Recall D-0619-2018 — InvaGen InvaGen Hello, I own a InvaGen that is covered by recall D-0619-2018 from InvaGen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0619-2018 (March 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0619-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.