CLASS II Drug recall · Reported 25 Oct 2017 · FDA Enforcement Report
Alprazolam Tablets recalled by The Harvard Drug Group
The Harvard Drug Group is recalling Alprazolam Tablets, USP, 0, distributed nationwide in the US. The recall was initiated on 26 Sep 2017 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-0013-2018
- FDA event ID
- 78162
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2017
- FDA classified
- 19 Oct 2017
- Reported
- 25 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 26 Sep 2017 | Recall initiated by company | |
| 19 Oct 2017 | Classified by FDA | +23 days |
| 25 Oct 2017 | 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
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
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, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Which lots are affected?
Lot 1274C151A, Exp 10/17
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.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | 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 |