CLASS II ONGOING Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report
Alprazolam C-IV, 0.5 mg, 30 Tabs recalled by Direct Rx
Direct Rx is recalling Alprazolam C-IV, 0.5 mg, 30 Tabs per, distributed nationwide in the US. The recall was initiated on 22 Mar 2023 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-0507-2023
- FDA event ID
- 92054
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2023
- FDA classified
- 6 Apr 2023
- Reported
- 12 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Anxiety & Sleep Medication
Timeline
| 22 Mar 2023 | Recall initiated by company | |
| 6 Apr 2023 | Classified by FDA | +15 days |
| 12 Apr 2023 | 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
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Product as listed by the FDA
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Which lots are affected?
Lot: 11AP2219 Exp. 4/30/23
Where was it sold?
Nationwide in the USA
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.
Other products in this recall event
2 other products · FDA event 92054This product is part of a recall event; the main page for the event is Alprazolam C-IV, 1 mg recalled by Direct Rx.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Alprazolam C-IV, 1 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Alprazolam C-IV, 2 mg, 60 Tabs recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Direct Rx
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine D/R, a) 30 mg recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophth Solution recalled by Direct Rx | Direct Rx | Packaging Defects | 5 states |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |
Other Alprazolam C-iv recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprazolam C-IV, 2 mg, 60 Tabs recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam C-IV, 1 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam C-IV 2 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | FL, GA, LA |
| Drug | CLASS II | Alprazolam C-IV 1 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | FL, GA, LA |