The Recall Desk
HighFDA (Drugs)·D-0645-2024·Announced 2024-09-04

IBU Prescription Ibuprofen Tablets Recalled for Failed Impurity Specifications

Dr. Reddy's Laboratories is recalling 31,802 bottles of IBU Ibuprofen 600mg tablets due to failed impurity specifications. The product was distributed nationwide and in 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 is an FDA Class II pharmaceutical recall for impurity specification failures. Without reported illnesses or injuries documented, the severity rating is High per the rubric rather than Severe.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling IBU Ibuprofen 600mg tablets (Rx Only) due to impurity specification failures. Approximately 31,802 bottles distributed throughout the United States and Puerto Rico are affected.

Impurity testing revealed unknown compounds at 0.13% and 0.11%, exceeding the 0.10% specification limit. This represents a manufacturing quality-control failure. The recall affects two NDC numbers: 55111-683-01 (100-tablet bottles) and 55111-683-05 (500-tablet bottles).

Specific lot numbers and expiration dates are available from the FDA and Dr. Reddy's Laboratories to help identify affected product. Consumers and healthcare providers should check these resources to determine if their product is affected. Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance before taking any action, as abrupt discontinuation should be discussed with a healthcare professional.

This is an FDA Class II recall.

The recalled product

Product
IBU (IBUPROFEN)
Brand
IBU
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug
Hazard
Affected units
31,802

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 (14)

  • a)NDC 55111-683-01 Lots C2207527
  • Exp 5/31/2026
  • C2210864
  • Exp 9/30/2026
  • C2213018
  • Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528
  • C2210860
  • C2213016
  • C2213017
  • Exp 11/30/2026
  • C2301852
  • C2302056
  • C2302057
  • Exp 1/31/2027.

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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