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Unrated Drug recall · FDA · Published June 30, 2021

Promise Pharmacy Recalls MIC+Methyl B12 Injection Due to Processing Control Issues

Promise Pharmacy recalls a specific MIC+Methyl B12 injection vial due to lack of processing controls. This medication is prescription-only and may pose risks if not handled properly.

🇺🇸 FDA recall #D-0803-2021DrugPromise Pharmacy ›
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Recalling firmPromise Pharmacy, LLC31818 Us Highway 19 N · Palm Harbor, FL 34684-3713
✎ GovInfoNow plain-language explainer

Promise Pharmacy is recalling a prescription-only MIC+Methyl B12 injection vial because of processing control issues. This could affect the safety and effectiveness of the medication if not addressed. Read more at govinfonow.com/recall/36103-promise-pharmacy-recalls-mic-methyl-b12-injection-due-to-processing.

Source Summary by GovInfoNow · govinfonow.com/recall/36103-promise-pharmacy-recalls-mic-methyl-b12-injection-due-to-processing · Updated August 18, 2026 · FDA enforcement record: FDA #D-0803-2021

Cite this page

“Promise Pharmacy Recalls MIC+Methyl B12 Injection Due to Processing Control Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36103-promise-pharmacy-recalls-mic-methyl-b12-injection-due-to-processing. Based on FDA recall #D-0803-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0803-2021%22&limit=1).

The FDA announced on June 30, 2021, that Promise Pharmacy, LLC voluntarily recalled MIC+Methyl B12 injection due to a lack of processing controls. The recall affects 57 vials distributed in Arizona, Colorado, Florida, Illinois, and New Jersey.

How to tell if you have it

  • Brand: Promise Pharmacy
  • Product: MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only
  • Lot#: 06152021@2
  • Expiration: 09/13/2021

The hazard

The recall was initiated because of a lack of processing controls. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Promise Pharmacy, LLC has two other recalls on record since October 18, 2018. On December 17, 2018, the company recalled Folic Acid Injection due to a lack of sterility assurance. Other recent recalls of similar products include Sagent Busulfan Injection Recall (May 4, 2026) and Baxter Healthcare Daptomycin Injection Recall (August 6, 2026).

How to tell if you have this one

Check for the vial labeled 'MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx' from Promise Pharmacy. The lot number is 06152021@2 and expiration date is 09/13/2021.

  • Brand
    Promise Pharmacy
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Vial Details

    Look for the specific vial label and lot number 06152021@2 with expiration date 09/13/2021.

Where it went and when

Where it was distributed

Distributed in 5 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: 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: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: 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: not listedTXFlorida: yesFL

FDA distribution: “AZ, CO, FL, IL, NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Colorado, Florida, Illinois, New Jersey.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Jun 30, 202112. FDA classified it Class II: Sep 16, 202123. Published in FDA’s Enforcement Report: Sep 22, 202134. FDA terminated the recall: Jun 6, 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.

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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-0803-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0803-2021 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