FDA Drug recall D-0390-2026
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Ha…
- FDA Drug
- Class II
- ongoing
- Published 2026-03-25
On 2026-03-25 the FDA classified a Class II recall of Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Ha… by Strides Pharma, citing presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0390-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-02 |
| Published | 2026-03-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Strides Pharma |
| Distribution | US |
Product
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Reason
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Identifiers
| ndc | 51672-5321-8 |
|---|---|
| ndc | 51672-5321-1 |
| code_info | Lot: 7261973A, 7261974A, Exp 01/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0390-2026%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.