FDA Recall D-0390-2026

STRIDES PHARMA INC · Bridgewater, NJ

Class II Ongoing 73 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot: 7261973A, 7261974A, Exp 01/31/2027

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.

Recall record

Recall number: D-0390-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2026-03-02
Classified by FDA Center: 2026-03-16
FDA published: 2026-03-25
Recalling firm: STRIDES PHARMA INC
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): IBUPROFEN
Generic name(s): IBUPROFEN
Manufacturer(s): TARO PHARMACEUTICALS U.S.A., INC.
NDC(s): 51672-5321
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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