Class II · ModerateRecall completed
Ibuprofen Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18
Where it was soldDistributed to repackaging firms in NY who then distributed Nationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMarksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India foreign manufacturer
| Distributed by / for | Marksans Pharma Inc. |
| NDC | 25000-121-29 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Marksans Pharma Inc. |
| Distribution | Distributed to repackaging firms in NY who then distributed Nationwide in the USA. |
| Quantity | 21,584,100 tablets |
| Recall initiated | 2018-01-09 |
| Report date | 2018-01-31 |
| Recall completed | 2020-05-26 |
| Recall number | D-0238-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Hauppauge NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.