American Regent recall: Epinephrine Injection
American Regent, Inc. is recalling Epinephrine Injection because of a sterility problem – 31,935 30mL-vials. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on August 11, 2026. Distributed nationwide.
Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.
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| Product | Epinephrine Injection |
| Brand | American Regent |
| Company | American Regent, Inc. |
| Type | Drugs |
| Classification | Class I |
| Recall date | August 11, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 31,935 30mL-vials |
| Recall ID | 99670 |
Recalled products
- Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
- FDA recall number
- D-0865-2026
- Codes, lots and dates
- Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027
- Quantity
- 31,935 30mL-vials
- Classification
- Class I
Identifiers and details
- FDA event ID
- 99670
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Shirley, NY, United States
Why it was recalled
The problem: a sterility problem.
The reason the FDA lists: “Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide within the U.S.A”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99670, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other American Regent recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Aug 26, 2026 |  American Regent recall: Nitroglycerin injection and 9 more productsDrugs · 98,200 vials; 235,350 vials; 26,450 vials; 63,200 vials; 89,775 vials; 316,450 vials; 169,200 vials; 41,680 vials; 185,775 vials; 86,100 vials; 323,000 vials; 43,460 vials | Presence of Particulate Matter: Product contaminated with particulate matter identified as… Most serious | FDA Class I |
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is American Regent Epinephrine Injection recalled?
Yes. American Regent, Inc. recalled it on August 11, 2026; FDA published it September 16, 2026 (Class I). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a sterility problem. The reason given: Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.