CLASS II Drug recall · Reported 3 Nov 2021 · FDA Enforcement Report
Benzalkonium Chloride 013% Solution recalled by First Royal Care Co. LLC
First Royal Care Co. LLC is recalling Benzalkonium Chloride 013% Solution, distributed in 7 states. The recall was initiated on 13 Aug 2021 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-0055-2022
- FDA event ID
- 88693
- Recalling firm
- First Royal Care Co. LLC, Mesa, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2021
- FDA classified
- 26 Oct 2021
- Reported
- 3 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 13 Aug 2021 | Recall initiated by company | |
| 26 Oct 2021 | Classified by FDA | +74 days |
| 3 Nov 2021 | 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
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
Where it was distributed
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Questions about this recall
Is Benzalkonium Chloride 013% Solution recalled?
Yes. First Royal Care Co. LLC recalled Benzalkonium Chloride 013% Solution on 13 Aug 2021. The recall is Class II and its status is Terminated. Recall number D-0055-2022.
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Which lots are affected?
all lots within expiry
Where was it sold?
494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
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.
More recalls from First Royal Care Co. LLC
All 140| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Acetylcysteine 2% Opth Soln recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Mic/b12a/b6 15/50/100 5mg/50mg/ML Mdv recalled | First Royal Care Co. LLC | Sterility | 7 states |
| Drug | CLASS II | Levocarnitine 100mg/ML Mdv Soln recalled by First Royal Care Co. LLC | First Royal Care Co. LLC | Sterility | 7 states |