CLASS II Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report
Alprazolam Tablets, USP, 0.25mg recalled by Sandoz Incorporated
Sandoz is recalling Alprazolam Tablets, USP, 0.25mg, distributed nationwide in the US. The recall was initiated on 25 Jul 2014 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-1509-2014
- FDA event ID
- 68900
- Recalling firm
- Sandoz, Broomfield, CO
- Brand
- Alprazolam
- Manufacturer
- Sandoz Inc
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jul 2014
- FDA classified
- 31 Jul 2014
- Reported
- 6 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Anxiety & Sleep Medication
Timeline
| 25 Jul 2014 | Recall initiated by company | |
| 31 Jul 2014 | Classified by FDA | +6 days |
| 6 Aug 2014 | 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
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Product as listed by the FDA
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Which lots are affected?
Lot EJ9591
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.
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Other Alprazolam recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by ViatrisXanax | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP, 2 mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP, 0.5mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP, 0.25mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP, 1 mg, CIV recalled | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |