Children's Ibuprofen Oral Suspension recall
FDA recall D-0390-2026 · initiated Mar 2, 2026
STRIDES PHARMA INC recalled Children's Ibuprofen Oral Suspension in Mar 2026 — an FDA Class II recall (D-0390-2026) because Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 89592 bottles
Details
- 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.
- Recalling company
- Strides Pharma Intl
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. Nationwide
- Initiated
- Mar 2, 2026
- FDA report date
- Mar 25, 2026
Frequently asked
- Was Children's Ibuprofen Oral Suspension recalled?
- STRIDES PHARMA INC recalled Children's Ibuprofen Oral Suspension in Mar 2026 — an FDA Class II recall (D-0390-2026) because Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Children's Ibuprofen Oral Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0390-2026 was: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
- Is a recalled Children's Ibuprofen Oral Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Children's Ibuprofen Oral Suspension are affected?
- Distributed: U.S.A. Nationwide. The recall covers these lots — Lot: 7261973A, 7261974A, Exp 01/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0390-2026.