CLASS II Drug recall · Reported 30 Nov 2016 · FDA Enforcement Report
Phenobarbital Tablets, USP 60mg 100=count recalled
West-Ward Pharmaceuticals is recalling Phenobarbital Tablets, USP 60mg 100=count, distributed nationwide in the US. The recall was initiated on 3 Oct 2016 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-1045-2017
- FDA event ID
- 75261
- Recalling firm
- West-Ward Pharmaceuticals, Eatontown, NJ
- Brand
- Phenobarbital
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Oct 2016
- FDA classified
- 18 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 3 Oct 2016 | Recall initiated by company | |
| 18 Nov 2016 | Classified by FDA | +46 days |
| 30 Nov 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
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
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Which lots are affected?
Lot #: 71294A, Exp. 5/2017
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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|---|---|---|---|---|---|
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Other Phenobarbital recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled by Monarch PCM | Monarch PCM | Other | TN |
| Drug | CLASS II | Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide |
| Drug | CLASS II | Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium | Vitae Enim Vitae Scientific | Sterility | Nationwide |
| Drug | CLASS II | Phenobarbital Tablets, USP 32.4 mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Phenobarbital Oral Solution, USP, 20 mg recalled by Torrent Pharma | Torrent Pharma | Sterility | Nationwide |