Reported Sep 4, 2024 · Ongoing
IBU Ibuprofen Tablets, USP, 800 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, 800 mg, Rx Only
- DistributorDr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 NDC 55111-684-01 Lots C2207525, Exp 5/31/2026 2 C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026 3 C2210751, C2210752, Exp 9/30/2026 4 C2212765, C2212766, Exp 11/30/2026 5 C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026 6 C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027 7 C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027 8 C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027. - Amount recalled
- 103,298 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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