CLASS II Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Incorporated Ibuprofen a) recalled by PD-Rx Pharmaceuticals
PD-Rx Pharmaceuticals is recalling Incorporated Ibuprofen a), distributed nationwide in the US. The recall was initiated on 25 Jan 2018 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-0341-2018
- FDA event ID
- 79023
- Recalling firm
- PD-Rx Pharmaceuticals, Oklahoma City, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jan 2018
- FDA classified
- 8 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 25 Jan 2018 | Recall initiated by company | |
| 7 Feb 2018 | Published in enforcement report | +13 days |
| 8 Feb 2018 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations.
Product as listed by the FDA
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP deviations.
Which lots are affected?
Lots: K16E92 Exp. 5/31/18; B17A87 Exp. 5/31/18; E17A51 Exp. 5/31/18; L16B59 Exp. 1/31/18; K16E01 Exp. 5/31/18; A17F21 Exp. 5/31/18; B17D71 Exp. 5/31/18; D17E92 Exp. 5/31/18; J16D13 Exp. 1/31/18; A17D63 Exp. 5/31/18; E17A18 Exp. 5/31/18; F17B87 Exp. 5/31/18; C17C58 Exp. 5/31/18
Where was it sold?
Nationwide
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 PD-Rx Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Nitrosamine Impurity | FL, MS, WI |
| Drug | CLASS II | Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |