Reported Sep 4, 2024 · Ongoing
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in…
Dr. Reddy's Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- IBU Ibuprofen Tablets, USP, 600 mg, Rx Only
- DistributorDr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 NDC 55111-683-01 Lots C2207527, Exp 5/31/2026 2 C2210864, Exp 9/30/2026 3 C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026 4 C2210860, Exp 9/30/2026 5 C2213016, C2213017, Exp 11/30/2026 6 C2301852, C2302056, C2302057, Exp 1/31/2027. - Amount recalled
- 31,802 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
This product could cause temporary or reversible health problems — stop using it.
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