CLASS III Drug recall · Reported 25 May 2022 · FDA Enforcement Report
Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled by Monarch PCM
Monarch PCM is recalling Phenobarbital Elixir, USP 20 mg/, 1 Pint, distributed in Tennessee. The recall was initiated on 14 Apr 2022 and the FDA has classified it as Class III.
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-0878-2022
- FDA event ID
- 90062
- Recalling firm
- Monarch PCM, Fort Worth, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Apr 2022
- FDA classified
- 17 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 14 Apr 2022 | Recall initiated by company | |
| 17 May 2022 | Classified by FDA | +33 days |
| 25 May 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Product as listed by the FDA
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
Where it was distributed
TN only
Questions about this recall
Is Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled?
Yes. Monarch PCM recalled Phenobarbital Elixir, USP 20 mg/, 1 Pint on 14 Apr 2022. The recall is Class III and its status is Terminated. Recall number D-0878-2022.
Why was it recalled?
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Which lots are affected?
Lot #: 20FP1569 Exp. Date 08/2022; 21FP1674 Exp. Date 02/2023; 21FP1831 Exp. Date 08/2023
Where was it sold?
TN only
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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