Class II · Moderate risk
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Children's Ibuprofen Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
51672-5321-08
Compare with the code on your package — it is the most precise check available.
Drug: Ibuprofen Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| ibuprofen NDC 51672-5321 |
100 mg/5mL | Suspension Oral |
Sun Pharmaceutical Industries, Inc. | OTC |
- Recalling firm
- Strides Pharma INC
- NDC code
- 51672-5321-8
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0390-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Ibuprofen recalls
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Class II · Moderate risk
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CGMP Deviations
Class III · Low risk
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Class II · Moderate risk
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Class II · Moderate risk
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Failed Impurities/Degradation Specifications - at 18-month Stability testing
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Class II · Moderate risk
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Testosterone Gel 1%
Presence of foreign substance: Presence of Benzene.
Class II · Moderate risk
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Failed Dissolution Specifications
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