FDA Drug recall D-0301-2020
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Ph…
- FDA Drug
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Ph… by Taro Pharmaceuticals U, citing presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0301-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-27 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
Product
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1
Reason
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Identifiers
| ndc | 51672-2130-8 |
|---|---|
| ndc | 51672-2130-1 |
| code_info | Lot #: J871033187, Exp 9/20 |
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-0301-2020%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.