FDA Drug recall D-0235-2018
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging,…
- FDA Drug
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging,… by Marksans Pharma, citing CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0235-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-09 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Marksans Pharma |
| Distribution | US |
Product
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped 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 25000-117-30.
Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Identifiers
| ndc | 25000-114-03 |
|---|---|
| ndc | 25000-114-14 |
| ndc | 25000-114-20 |
| ndc | 25000-114-30 |
| ndc | 25000-114-98 |
| ndc | 25000-114-93 |
| ndc | 25000-114-70 |
| ndc | 25000-114-71 |
| ndc | 25000-114-02 |
| ndc | 25000-117-03 |
| ndc | 25000-117-14 |
| ndc | 25000-117-20 |
| ndc | 25000-117-30 |
| ndc | 25000-117-98 |
| ndc | 25000-117-93 |
| ndc | 25000-117-69 |
| ndc | 25000-117-02 |
| code_info | Lot #: HH6001, HH6002, Exp 04/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0235-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.