Prescription Ibuprofen Tablets Recalled for Excessive Unknown Impurities
Dr. Reddy's Laboratories is recalling IBU Ibuprofen 400 mg prescription tablets due to impurity levels exceeding specifications. The recall affects 14,940 bottles distributed nationwide in the USA and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves actual manufacturing contamination with unknown impurities exceeding specification limits in a prescription medication. While no illnesses or injuries have been reported, the presence of unidentified contaminants represents a potential health risk meeting the criteria for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling IBU (Ibuprofen) 400 mg prescription tablets distributed nationwide in the USA and Puerto Rico. The recall involves 14,940 bottles with multiple lot numbers and expiration dates between May and November 2026.
The recall was initiated due to failed quality specifications for impurities and degradation. Laboratory testing identified unknown impurity levels of 0.13% and 0.11% in affected batches, exceeding the specification limit of 0.10%.
Affected lot numbers include C2207529 and C2210993 (NDC 55111-682-01: 100-tablet bottles) and C2207530, C2210992, C2210994, C2213304, and C2213305 (NDC 55111-682-05: 500-tablet bottles). The product is manufactured in India and distributed by Dr. Reddy's Laboratories Inc. in Princeton, New Jersey.
The recalled product
- Product
- IBU (IBUPROFEN)
- Brand
- IBU
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- a)NDC 55111-682-01 Lots C2207529
- Exp 5/31/2026
- C2210993
- Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530
- C2210992
- C2210994
- Exp 9/30/2026
- C2213304
- C2213305
- Exp 11/30/2026.
Distribution
Distributed nationwide across the United States.
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