Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported May 25, 2022
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
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Monarch Pcm, LLC recalled Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured fo… - a low-severity action.
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured fo… was recalled by Monarch Pcm, LLC in May 25, 2022. Reason: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content. Check the official notice for the remedy. Verify recall #D-0878-2022 with the FDA Drug before acting.
The recall
Monarch Pcm, LLC issued this low-severity FDA Drug recall-Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content.
- Low
- severity level
- Class III
- classification
- May 25, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0878-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0878-2022) was formally reported on May 25, 2022, with the manufacturer initiating the action on April 14, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Monarch Pcm, LLC is listed as the recalling firm, operating out of Fort Worth, TX. Federal records list the affected scope as 15,730 bottles.
The documented reason for this recall is: Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content Distribution data in the federal record shows the product reached: TN only. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15,730 bottles
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0878-2022 |
| Date reported | May 25, 2022 |
| Date initiated | April 14, 2022 |
| Recalling firm | Monarch Pcm, LLC |
| Firm location | Fort Worth, TX |
| Affected scope | 15,730 bottles |
| Distribution | TN only |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0878-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Monarch Pcm, LLC. Units affected: 15,730 bottles.
Why was this product recalled? ▼
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2022. Severity: Low. Recall number: D-0878-2022.
Where was the recalled product distributed? ▼
Distribution: TN only.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0878-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie c…
AbbVie Inc. · 2026-06-03
FDA Food Moderate
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
FDA Drug Moderate
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
FDA Drug Moderate
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
Lupin Pharmaceuticals Inc. · 2026-05-27
Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 25, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.