The Recall Desk
HighFDA (Drugs)·D-0644-2024·Announced 2024-09-04

Prescription Ibuprofen Recalled Due to Failed Impurity Specifications

Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.

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 is an FDA Class II recall for a prescription medication with unknown impurities exceeding quality specifications. The hazard represents a risk of harm from pharmaceutical impurities, matching the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling IBU (Ibuprofen) Tablets, USP, 800 mg (prescription only) distributed nationwide in the USA and Puerto Rico. The recall affects 103,298 bottles in two package sizes: NDC 55111-684-01 (100-tablet bottles) and NDC 55111-684-05 (500-tablet bottles), with expiration dates ranging from May 2026 through March 2027.

The recall was initiated because testing identified failed impurities/degradation specifications. Test results showed unknown impurity levels of 0.13% and 0.11%, both exceeding the acceptable specification limit of 0.10%.

Patients currently taking these tablets should not discontinue use without consulting their healthcare provider. Consumers who have purchased affected bottles should contact their pharmacy or healthcare provider immediately to confirm whether they have an affected lot. The FDA classifies this as a Class II recall.

The recalled product

Product
IBU (IBUPROFEN)
Brand
IBU
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug
Hazard
Affected units
103,298

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 (20)

  • a) NDC 55111-684-01 Lots C2207525
  • Exp 5/31/2026
  • C2212902
  • Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526
  • C2210751
  • C2210752
  • Exp 9/30/2026
  • C2212765
  • C2212766
  • Exp 11/30/2026
  • C2301027
  • C2301063
  • C2301187
  • C2301188
  • C2301247
  • Exp 12/31/2026
  • C2301356
  • C2301388
  • C2301494
  • C2301478

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · IBU

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · unknown impurity

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