Ibuprofen Tablets USP 600 mg — Class II drug recall D-0690-2018
Terminated recall by Time-Cap Laboratories, Inc., reported 2018-05-02, distributed nationwide. CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor r
| Recall number | D-0690-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Time-Cap Laboratories, Inc., Farmingdale, NY, United States |
| Recall initiated | 2018-01-11 |
| Classified | 2018-04-22 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2021-01-20 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 42582-0112-10, 42582-0112-18 |
Product
Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
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-0690-2018. 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.