CLASS II ONGOING Drug recall · Reported 4 Sep 2024 · FDA Enforcement Report
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled
Preferred Pharmaceuticals is recalling Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: per, Mfg: Dr, distributed in California, Nevada. The recall was initiated on 8 Aug 2024 and the FDA has classified it as Class II.
Check your package
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-0647-2024
- FDA event ID
- 95132
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Aug 2024
- FDA classified
- 26 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 8 Aug 2024 | Recall initiated by company | |
| 26 Aug 2024 | Classified by FDA | +18 days |
| 4 Sep 2024 | Published in enforcement report | +9 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 - at 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 Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Where it was distributed
CA and NV
Questions about this recall
Is Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: per, Mfg: Dr recalled?
Yes. Preferred Pharmaceuticals recalled Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: per, Mfg: Dr on 8 Aug 2024. The recall is Class II and its status is Ongoing. Recall number D-0647-2024.
Why was it recalled?
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Which lots are affected?
Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
Where was it sold?
CA and NV
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 21 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 Preferred Pharmaceuticals
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Cap USP 30mg recalled | Preferred Pharmaceuticals | Nitrosamine Impurity | 5 states |
| Drug | CLASS II | Tizanidine Hydrochloride Tablet 4mg recalledTizanidine | Preferred Pharmaceuticals | Potency & Assay | Nationwide |
Other Ibuprofen recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIbu | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIbu | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIbu | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 800 mg recalled by Dr. Reddy's LaboratoriesIbu | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |