FDA DrugsClass II
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bott...
Published: March 25, 2026Recall ID: D-0390-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Bridgewater |
| State | NJ |
| Openfda › Nui › 1 | N0000000160 |
| Openfda › Nui › 2 | M0001335 |
| Openfda › Nui › 3 | N0000175722 |
| Openfda › Upc | 0351672532185 |
| Openfda › Unii | WK2XYI10QM |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 197803 |
| Openfda › Spl id | b7b5ccd2-1de9-4b93-b2bb-09bc540704fd |
| Openfda › Brand name | IBUPROFEN |
| Openfda › Spl set id | 9de61620-6750-4fb6-89a4-fe451ab8d99f |
| Openfda › Package ndc › 1 | 51672-5321-8 |
| Openfda › Package ndc › 2 | 51672-5321-1 |
| Openfda › Product ndc | 51672-5321 |
| Openfda › Generic name | IBUPROFEN |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs | Anti-Inflammatory Agents, Non-Steroidal [CS] |
| Openfda › Substance name | IBUPROFEN |
| Openfda › Pharm class epc | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Openfda › Pharm class moa | Cyclooxygenase Inhibitors [MoA] |
| Openfda › Manufacturer name | TARO PHARMACEUTICALS U.S.A., INC. |
| Openfda › Application number | ANDA211666 |
| Openfda › Is original packager | true |
| Event id | 98508 |
| Address 1 | 200 Crossing Blvd Ste 110 |
| Address 2 | N/A |
| Code info | Lot: 7261973A, 7261974A, Exp 01/31/2027 |
| Postal code | 08807-2861 |
| Report date | 20260325 |
| Product type | Drugs |
| Product quantity | 89592 bottles |
| Reason for recall | Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260302 |
| Initial firm notification | Letter |
| Center classification date | 20260316 |
Overview
- Recalling FirmSTRIDES PHARMA INC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S.A. Nationwide