CLASS II Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Alprazolam Tablets, USP, 0.25 mg recalled by Mylan Institutional, Inc.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Alprazolam Tablets, USP, 0.25 mg, per, distributed nationwide in the US. The recall was initiated on 18 Jan 2019 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-1013-2019
- FDA event ID
- 81946
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2019
- FDA classified
- 20 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 18 Jan 2019 | Recall initiated by company | |
| 20 Mar 2019 | Classified by FDA | +61 days |
| 27 Mar 2019 | Published in enforcement report | +7 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: Elevated levels of a known impurity detected during 6-month RT stability interval.
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
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Which lots are affected?
Lots: 3095198, 3096266, 3098776, EXP 05-2019
Where was it sold?
Nationwide USA and Puerto Rico
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 Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other 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 |