FDA Drug recall D-0583-2018
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
- FDA Drug
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1 by Spirit Pharmaceuticals, citing CGMP deviations: Ibuprofen is being recalled in response to previous recall.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0583-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-10 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Spirit Pharmaceuticals |
| Distribution | NY |
Product
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Reason
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Identifiers
| ndc | 68210-0800-1 |
|---|---|
| ndc | 68210-0800-4 |
| code_info | Lot#: HJ6138 |
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-0583-2018%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.