Skip to content
Get alerts
GovInfoNow
Unrated Drug recall · FDA · Published August 13, 2021

Red Mountain Compounding Pharmacy Recalls B6 Vitamin Shots Due to Sterility Concerns

Red Mountain Compounding Pharmacy recalls all PYRIDOXINE HCL (B6) : FDA inspection raised sterility assurance concerns. No remedy specified in recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0041-2022DrugRed Mountain Compounding Pharmacy ›
Take action

Contact the company

Recalling firmFirst Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy6828 E Brown Rd Ste 101 · Mesa, AZ 85207-3761
✎ GovInfoNow plain-language explainer

Red Mountain Compounding Pharmacy is recalling all PYRIDOXINE HCL (B6) 100MG/ML MDV products due to sterility concerns identified during FDA inspection. This could pose a risk of infection if the medication is not properly sterile. Read more at govinfonow.com/recall/35934-red-mountain-compounding-pharmacy-recalls-b6-vitamin-shots-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/35934-red-mountain-compounding-pharmacy-recalls-b6-vitamin-shots-due-to · Updated August 18, 2026 · FDA enforcement record: FDA #D-0041-2022

Cite this page

“Red Mountain Compounding Pharmacy Recalls B6 Vitamin Shots Due to Sterility Concerns.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35934-red-mountain-compounding-pharmacy-recalls-b6-vitamin-shots-due-to. Based on FDA recall #D-0041-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0041-2022%22&limit=1).

The FDA announced on 2021-08-13 that First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy is recalling PYRIDOXINE HCL (B6) 100MG/ML MDV due to sterility assurance concerns raised during an inspection. The voluntary Class II recall affects all lots within expiry distributed to patients in AZ, CA, FL, MN, MT, TX, and UT.

How to tell if you have it

  • Brand: Red Mountain Compounding Pharmacy
  • Product: PYRIDOXINE HCL (B6) 100MG/ML MDV
  • Distribution: 494 patients/consumers in AZ, CA, FL, MN, MT, TX, and UT

The hazard

The FDA inspection raised sterility assurance concerns regarding the product. The recall covers all lots within expiry.

Context

GovInfoNow's records show First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy has one other recall on record since 2019-08-12, specifically a 2019-08-12 recall of Estradiol Injections due to sterility risk. Other recent recalls of similar products include Reliance Pemetrexed Injection Recall (2026-06-24), Apothecary Pharma Recalls Tirzepatide Injections (2026-09-24), and Teva Octreotide Acetate 20mg Vial Recall (2026-03-17).

How to tell if you have this one

Check for the product name 'PYRIDOXINE HCL (B6) 100MG/ML MDV' from Red Mountain Compounding Pharmacy. All lots within the expiration date are included in this recall.

  • Brand
    Red Mountain Compounding Pharmacy
  • Category
    Drug
FDA recall event · 40 products

All 40 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.
Recall numberProduct, codes & lots
D-0028-2022Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0029-2022Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0030-2022LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0031-2022ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0032-2022ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0033-2022ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0034-2022CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0035-2022CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0036-2022DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0037-2022ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0038-2022GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0039-2022HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0040-2022LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0041-2022PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx; all lots within expiry
D-0042-2022TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0043-2022TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0044-2022TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0045-2022TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0046-2022TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0047-2022TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0048-2022TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0049-2022TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0050-2022TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0051-2022VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0052-2022VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0053-2022ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx; all lots within expiry
D-0054-2022ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0055-2022BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0056-2022CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0057-2022FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0058-2022METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0059-2022METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0060-2022METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0061-2022METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0062-2022MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx; all lots within expiry
D-0063-2022MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx; all lots within expiry
D-0064-2022MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0065-2022MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0066-2022PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx; all lots within expiry
D-0067-2022SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx; all lots within expiry
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product name 'PYRIDOXINE HCL (B6) 100MG/ML MDV' from Red Mountain Compounding Pharmacy.

Where it went and when

Where it was distributed

Distributed in 7 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: yesMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Florida, Minnesota, Montana, Texas, Utah.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Aug 13, 202112. FDA classified it Class II: Oct 26, 202123. Published in FDA’s Enforcement Report: Nov 3, 202134. FDA terminated the recall: Apr 12, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

American Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, IncPreferred Pharma Recalls Lidocaine Ointment Due to Content Issues
Preferred Pharmaceuticals, Inc.Northstar Rx Recalls Tretinoin Cream Due to Impurities
SUN PHARMACEUTICAL INDUSTRIES INCApothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk
Apothecary Pharma LLC

Latest drug recalls

Apotex Corp. recalls Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario,
Apotex · September 23, 2026Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx
Cipla USA · September 18, 2026Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc.,
Ajanta Pharma · September 17, 2026Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company recalls Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with
Insight Pharmaceuticals · September 15, 2026K.C. Pharmaceuticals, Inc. recalls Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO
Leader / TopCare / Crocodile Tears · September 11, 2026Amneal Pharmaceuticals, LLC recalls Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater,
Amneal Pharmaceuticals · September 8, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0041-2022 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0041-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA