McGuff Compounding Pharmacy recalls Lipoic Acid Injection vials with visible particulate matter. This may cause injection site reactions. Check your vial lot number for affected units.
“McGuff Lipoic Acid Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39250-mcguff-lipoic-acid-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0802-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0802-2020%22&limit=1).
McGuff Compounding Pharmacy Services, Inc. recalled Lipoic Acid Injection due to the presence of particulate matter, according to the FDA. The recall was announced on January 10, 2019.
How to tell if you have it
Brand: McGuff
Product: Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial
Lot #: 18M0991
Preparation #: 390-2678
Beyond Usage Date: 06/15/2019
The hazard
The recall is due to the presence of particulate matter, specifically filmy or cloudy particulate observed in the vials.
Context
GovInfoNow's records show McGuff Compounding Pharmacy Services, Inc. has two other recalls on record since February 14, 2019. Other recent recalls of similar products include Lupin Liraglutide 18mg/3mL Injection Recall (April 24, 2026), American Regent Papaverine HCl Injection Recall (July 24, 2026), and Mallinckrodt Acthar Gel 5mL Vial Recall (August 6, 2026).
How to tell if you have this one
Check your vial for filmy or cloudy particles. Affected vials have lot number 18M0991 and preparation number 390-2678, made before June 15, 2019.
Brand
McGuff
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Condition
Inspect the vial for filmy or cloudy particles. If present, do not use the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.9 years after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0802-2020 (January 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0802-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.