DCA Pharmacy Recalls Sermorelin Due to Sterility Risks
DCA Pharmacy recalls Sermorelin 6mg/6mL powder due to lack of sterility assurance. Check lot #101614 if you have this drug.
Stop using this now
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Contact the company
What happened, in plain English
Diabetes Corporation of America dba DCA Pharmacy is recalling one lot of Sermorelin 6mg/6mL Lyophilized Powder because it may not be sterile. An FDA inspection found the product was compounded in an area inappropriate for lyophilization, which compromises sterility assurance. This affects 129 vials distributed to Kentucky, Ohio, and Tennessee. Read more at govinfonow.com/recall/43622-diabetes-corporation-of-america-dba-dca-pharmacy-recalls-sermorelin-6mg.
Source Summary by GovInfoNow · govinfonow.com/recall/43622-diabetes-corporation-of-america-dba-dca-pharmacy-recalls-sermorelin-6mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-0006-2016
Cite this page
“DCA Pharmacy Recalls Sermorelin Due to Sterility Risks.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43622-diabetes-corporation-of-america-dba-dca-pharmacy-recalls-sermorelin-6mg. Based on FDA recall #D-0006-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0006-2016%22&limit=1).
Why it’s dangerous
The product was not compounded in an area appropriate for lyophilization, leading to a lack of assurance that the sterile compound is actually sterile. Using a non-sterile injectable drug can introduce bacteria or contaminants directly into the body, causing serious infections.
Who’s affected
Patients in Kentucky, Ohio, or Tennessee who purchased Sermorelin from DCA Pharmacy before April 30, 2015. Individuals using this specific compounded injection are at risk of infection due to potential lack of sterility.
How to tell if you have this one
Look for Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection manufactured by Diabetes Corporation of America dba DCA Pharmacy. Check if the lot number is 101614 and the expiration date is 4/30/2015.
- Brand
DCA Pharmacy- Category
Drug
What to do — step by step
Stop using the medication
Do not use the Sermorelin powder if it matches the recalled lot number.
Contact your pharmacy
Reach out to DCA Pharmacy or your healthcare provider for instructions on returning or disposing of the product.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “KY, OH, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kentucky, Ohio, Tennessee.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-0006-2016 (September 23, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0006-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.