CLASS II Drug recall · Reported 19 Mar 2014 · FDA Enforcement Report
Alprazolam recalled by Actavis Elizabeth
Actavis Elizabeth is recalling Alprazolam, USP, distributed nationwide in the US. The recall was initiated on 10 Feb 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-1153-2014
- FDA event ID
- 67519
- Recalling firm
- Actavis Elizabeth, Elizabeth, NJ
- Brand
- Alprazolam
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2014
- FDA classified
- 10 Mar 2014
- Reported
- 19 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 10 Feb 2014 | Recall initiated by company | |
| 10 Mar 2014 | Classified by FDA | +28 days |
| 19 Mar 2014 | 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 Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Product as listed by the FDA
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.
Which lots are affected?
Lot # 1826E131, Exp 04/2015
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 Actavis Elizabeth
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth | Actavis Elizabeth | Other | NJ |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
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 |