FDA Recall Ibuprofen
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Ibuprofen with NDC 25000-123 was initiated on 01-09-2018 as a Class II recall due to cgmp deviations: various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to cgmp deficiencies. The latest recall number for this product is D-0239-2018 and the recall is currently terminated as of 05-26-2020 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0239-2018 | 01-09-2018 | 01-31-2018 | Class II | 23,088,900 tablets | Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28. | Terminated |
| D-0240-2018 | 01-09-2018 | 01-31-2018 | Class II | 52,549,000 tablets | Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27. | Terminated |
| D-0238-2018 | 01-09-2018 | 01-31-2018 | Class II | 21,584,100 tablets | Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29. | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.