Ibuprofen Tablets — Class II drug recall D-0239-2018
Terminated recall by Marksans Pharma Inc., reported 2018-01-31, distributed nationwide. CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor r
| Recall number | D-0239-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Marksans Pharma Inc., Hauppauge, NY, United States |
| Recall initiated | 2018-01-09 |
| Classified | 2018-01-24 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2020-05-26 |
| Distributed | Nationwide (US) |
| Quantity | 23,088,900 tablets |
| Reason classes | cgmp |
| NDC | 25000-0122-28 |
| Lot numbers | 03/18, 04/18, 07/18, 09/18, HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, HN6014, HN6015, HN6016, HN6017, HN6018, HN6019, HN6020, HN6021, HN6022, HN6023, HN6024, HN6025, HN6026, HN6027 |
Product
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.
Reason for recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0239-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.