CLASS II ONGOING Drug recall · Reported 13 Nov 2024 · FDA Enforcement Report

Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled

Direct Rx is recalling Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, distributed nationwide in the US. The recall was initiated on 9 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #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, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.

Quantity recalled1410 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0041-2025
FDA event ID: 95618
Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Aug 2024
FDA classified: 7 Nov 2024
Reported: 13 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Drug class: Pain Medication

Timeline

9 Aug 2024	Recall initiated by company
7 Nov 2024	Classified by FDA	+90 days
13 Nov 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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).

Where it was distributed

Nationwide in the US

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

Which lots are affected?

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, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.

Where was it sold?

Nationwide in the US

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Direct Rx

All 37

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
23 Apr 2025Drug	CLASS II	Ciprofloxacin Ophth Solution recalled by Direct Rx	Direct Rx	Packaging Defects	5 states
12 Apr 2023Drug	CLASS II	Alprazolam C-IV, 0.5 mg, 30 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide

Other Ibuprofen recalls

All 41

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen	Strides Pharma	Particulate Matter	Nationwide
27 Nov 2024Drug	CLASS III	IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Other	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled	Preferred Pharmaceuticals	Potency & Assay	CA, NV