CLASS II Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa
Lohxa is recalling Phenobarbital Oral Solution, USP 20 mg/, unit dose cup, distributed in Massachusetts, New York, Wyoming. The recall was initiated on 25 Mar 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-1131-2019
- FDA event ID
- 82538
- Recalling firm
- Lohxa, Worcester, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2019
- FDA classified
- 15 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 25 Mar 2019 | Recall initiated by company | |
| 15 Apr 2019 | Classified by FDA | +21 days |
| 17 Apr 2019 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Product as listed by the FDA
Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
Where it was distributed
MA, NY and WY
Questions about this recall
Is Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled?
Yes. Lohxa recalled Phenobarbital Oral Solution, USP 20 mg/, unit dose cup on 25 Mar 2019. The recall is Class II and its status is Terminated. Recall number D-1131-2019.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Which lots are affected?
Lot# M12031, Exp. 12/2019; T01241 Exp. 02/2020
Where was it sold?
MA, NY and WY
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 21 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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| Drug | CLASS II | Bismuth Subsalicylate Oral Suspension 262mg/, unit dose cups recalled | Lohxa | Other | MA, NY, WY |
Other Phenobarbital recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 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 |
| Drug | CLASS II | Phenobarbital Tablets USP, 100 mg, a) bottles recalled by C. O. Truxton | C. O. Truxton | Labeling Errors | Nationwide |