FDAClass IIIRecall started October 29, 2024

IBU 600 mg tablets Recall

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC…

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was IBU 600 mg tablets recalled?

Failed Tablet/Capsule Specifications

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Which lot codes, UPCs or models are affected?

Lot #: C5406201, Exp 03/31/2028

Agency record number
D-0047-2025
Product
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
3416 botttles
Distribution
USA Nationwide
Recall started
October 29, 2024
Report date
November 27, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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