IBU Ibuprofen Tablets recall
FDA recall D-0646-2024 · initiated Aug 6, 2024
Dr. Reddy's Laboratories, Inc. recalled IBU Ibuprofen Tablets in Aug 2024 — an FDA Class II recall (D-0646-2024) because Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 14940 bottles
Details
- Product
- IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Aug 6, 2024
- FDA report date
- Sep 4, 2024
Frequently asked
- Was IBU Ibuprofen Tablets recalled?
- Dr. Reddy's Laboratories, Inc. recalled IBU Ibuprofen Tablets in Aug 2024 — an FDA Class II recall (D-0646-2024) because Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was IBU Ibuprofen Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0646-2024 was: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Is a recalled IBU Ibuprofen 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 Tablets are affected?
- Distributed: Nationwide in the USA and Puerto Rico. The recall covers these lots — a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.. 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-0646-2024.