IBU (ibuprofen) 600 mg tablets recall
FDA recall D-0047-2025 · initiated Oct 29, 2024
Dr. Reddy's Laboratories, Inc. recalled IBU (ibuprofen) 600 mg tablets in Oct 2024 — an FDA Class III recall (D-0047-2025) because Failed Tablet/Capsule Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Tablet/Capsule Specifications
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3416 botttles
Details
- Product
- 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
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Oct 29, 2024
- FDA report date
- Nov 27, 2024
Frequently asked
- Was IBU (ibuprofen) 600 mg tablets recalled?
- Dr. Reddy's Laboratories, Inc. recalled IBU (ibuprofen) 600 mg tablets in Oct 2024 — an FDA Class III recall (D-0047-2025) because Failed Tablet/Capsule Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was IBU (ibuprofen) 600 mg tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0047-2025 was: Failed Tablet/Capsule Specifications
- Is a recalled IBU (ibuprofen) 600 mg tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of IBU (ibuprofen) 600 mg tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: C5406201, Exp 03/31/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0047-2025.