Ibuprofen Tablets USP — Class II drug recall D-0583-2018
Terminated recall by Spirit Pharmaceuticals, LLC, reported 2018-03-14, distributed in NY. CGMP deviations: Ibuprofen is being recalled in response to previous recall
| Recall number | D-0583-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spirit Pharmaceuticals, LLC, Ronkonkoma, NY, United States |
| Recall initiated | 2018-01-10 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2021-01-20 |
| Distributed | NY |
| Quantity | 144 bottles |
| Reason classes | cgmp |
| NDC | 68210-0800, 68210-0800-01, 68210-0800-04 |
| Lot numbers | HJ6138 |
Product
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Reason for recall
CGMP deviations: Ibuprofen is being recalled in response to previous recall
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-0583-2018. 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.