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.
What this means for you
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
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