Ibuprofen Caplets USP 200 mg — Class II drug recall D-0695-2018
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-0695-2018 |
|---|---|
| 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 | 53493-0292-12, 53493-0292-14, 53943-0292, 53943-0292-12, 53943-0292-14, 53943-0292-15 |
Product
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., 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-0695-2018. 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.