FDAFDA · Food and drugs·Recall number D-0646-2024
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
Published September 4, 2024 · Recall initiated: August 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
What to do
Voluntary: Firm initiated
Recall details
- Brand
- IBU
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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