The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1042-2013·Announced 2013-09-25

Dr. Reddy's Recalls IBU Ibuprofen Tablets Due to Incorrect Expiration Date

Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg tablets because the bottles display an incorrect expiration date of 05/2017 instead of 10/2016.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (incorrect expiration date). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are typically scored as Moderate (2).

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling IBU (Ibuprofen) Tablets, USP, 800 mg, 500-count bottles (NDC 55111-684-05). The recall is due to a labeling error where the expiration date is incorrectly printed as 05/2017, while the correct expiration date is 10/2016.

The affected product is Lot # L300192. A total of 18,852 bottles were distributed nationwide and in Puerto Rico. The product is a prescription-only medication.

Consumers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
IBU (IBUPROFEN)
Brand
IBU
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
18,852

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 (2)

  • Lot # L300192
  • Exp. 05/2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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