Ibuprofen 800mg recall
FDA recall D-0041-2025 · initiated Aug 9, 2024
Direct Rx recalled Ibuprofen 800mg in Aug 2024 — an FDA Class II recall (D-0041-2025) because Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 1410 bottles
Details
- Product
- Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
- Recalling company
- Direct Rx
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Aug 9, 2024
- FDA report date
- Nov 13, 2024
Frequently asked
- Was Ibuprofen 800mg recalled?
- Direct Rx recalled Ibuprofen 800mg in Aug 2024 — an FDA Class II recall (D-0041-2025) because Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ibuprofen 800mg recalled?
- Per the FDA enforcement record, the reason for recall D-0041-2025 was: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
- Is a recalled Ibuprofen 800mg 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 Ibuprofen 800mg are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot #s: a) 02FE2414, Exp 11/30/26. b) 18JU2407, Exp 11/30/26; 27JY2316, Exp 02/28/27; 13SE2317, 13OC2312, 23AU2307, Exp 03/31/27. c) 25SE2308, Exp 03/31/27. d) 29MA2313, 23MA2315, Exp 12/31/26; 25MY2304, Exp 01/31/27; 26JU2313, 27JY2314, Exp 02/28/27. e) 27SE2322, 30OC2304, 12OC2301, Exp 03/31/27. f) 11SE2322, 02FE2419…. 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-0041-2025.