Allergy Labs Recalls Ephedrine Sulfate Injection Due to Sterility Risks
Allergy Laboratories, Inc. recalls Ephedrine Sulfate Injection vials due to lack of sterility assurance. Check lot numbers and expiration dates for affected units.
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Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
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What happened, in plain English
Allergy Laboratories, Inc. is recalling Ephedrine Sulfate Injection, USP, 50 mg/mL single-dose vials because an FDA inspection raised concerns that the product's sterility may have been compromised. The recall covers approximately 1.9 million vials distributed nationwide. Patients and healthcare providers should check their inventory against the specific lot numbers listed in the record. Read more at govinfonow.com/recall/42487-allergy-labs-recalls-ephedrine-sulfate-injection-due-to-sterility-risks.
Source Summary by GovInfoNow · govinfonow.com/recall/42487-allergy-labs-recalls-ephedrine-sulfate-injection-due-to-sterility-risks · Updated October 11, 2026 · FDA enforcement record: FDA #D-1498-2016
Cite this page
“Allergy Labs Recalls Ephedrine Sulfate Injection Due to Sterility Risks.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42487-allergy-labs-recalls-ephedrine-sulfate-injection-due-to-sterility-risks. Based on FDA recall #D-1498-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1498-2016%22&limit=1).
Why it’s dangerous
The primary hazard is a lack of assurance of sterility. If the vials are not sterile, using them could introduce bacteria or other contaminants into the body, potentially causing serious infections or other adverse health effects.
Who’s affected
Healthcare facilities, pharmacies, and patients who have received or possess Ephedrine Sulfate Injection from Allergy Laboratories, Inc. are affected by this recall.
How to tell if you have this one
Look for Ephedrine Sulfate Injection, USP, 50 mg/mL, packaged in 1 mL fills in 2 mL vials (NDC: 69053-008-01) or cases of 25 x 2 mL vials (NDC: 69053-008-02). Affected lots include 102814, 102914, 103014, 103114, 110314, 110414, 110514, 110614, 110714, 111014, 121014, 121114, 121214, 121514, 011415, 011515, 011615, 012015, 012115, 021315, 021715, 021815, 021915, 022015, 030415, 030515, 030615, 031015, 031715, 042415, 042815, 042915, 043015, 050115, 050515, 052815, 052915, 060315, 060415, 061615, and 061715.
- Brand
Allergy Laboratories- Category
Drug
What to do — step by step
Stop using the product
Do not administer or use any Ephedrine Sulfate Injection vials that match the recalled lot numbers due to potential sterility issues.
Check lot numbers
Verify if your inventory contains lots 102814 through 061715 with expiration dates from 10/16 to 06/17.
Contact manufacturer
Reach out to Allergy Laboratories, Inc. or Andersen Pharmaceutical for further instructions on returning or disposing of the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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.
Questions people ask
What is the NDC for the recalled product?
The affected National Drug Codes are 69053-008-01 for single vials and 69053-008-02 for cases of 25 vials.
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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-1498-2016 (August 10, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1498-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.