American Regent, Inc. recalls
Every recall we track for American Regent, Inc. — 21 in all, from 2024–2026 — plus the complaints and injury reports the public filed about them. 12 are rated “stop using now”.
Recalls per year, by danger level
Recalls from American Regent, Inc. fell by more than half in 2025 (2, down from 5 in 2024). 57% rated “stop using now”.
All FDA recall records for American Regent, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 3 | 2 | 0 | 5 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 12 | 1 | 1 | 0 | 14 |
Most common reasons for American Regent, Inc. recalls
What to do if you have a recalled American Regent, Inc. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All American Regent, Inc. recalls
7 shown- Stop using nowDrug
American Regent, Inc. recalls Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion,
American Regent recalls epinephrine injections with particulate matter and lack of sterility. Affected lots expire August 2026 through July 2027. Stop using immediately if you have these vials.
American RegentAug 11, 2026 - Stop using nowDrug
American Regent, Inc. recalls ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b)
American Regent recalls 10% acetylcysteine solution vials due to contamination with hair, glass, and paraformaldehyde. Stop using if you have these vials.
American RegentJul 24, 2026 - Lower riskDrug
American Regent, Inc. recalls Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American
American Regent recalls Levocarnitine Injection vials with missing labels. This labeling issue may lead to incorrect use. Contact the manufacturer for details.
American RegentApr 16, 2026 - Lower riskDrug
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica,
American Regent recalls certain niCARdipine Hydrochloride Injection vials due to potential contamination from leakage around the vial neck. This could lead to lack of sterility assurance in medical use.
American RegentApr 18, 2025 - Use cautionDrug
American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For
American Regent recalls Venofer iron injection vials due to potential glass delamination. Stop using if you have these vials.
American RegentNov 11, 2024 - Lower riskDrug
American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For
American Regent recalls 10 vials of niCARdipine Hydrochloride injection (25 mg/10 mL) due to lack of sterility assurance. This could cause infections if used improperly.
American RegentMay 14, 2024 - Lower riskDrug
American Regent, Inc. recalls Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous
American Regent recalls vasopressin injection vials due to subpotent product and impurities. This medication is for IV use only and requires immediate action.
American RegentMay 13, 2024
American Regent, Inc. recall questions
How many recalls has American Regent, Inc. had?
21 recalls from American Regent, Inc. are on record with U.S. safety agencies, from 2024–2026.
What is the most recent American Regent, Inc. recall?
American Regent, Inc. recalls Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion,, dated Aug 11, 2026. Every American Regent, Inc. recall is listed on this page, newest first.
Why are American Regent, Inc. products recalled?
The most common reasons on record: Presence of Particulate Matter: Potential for glass delamination from the vials. (3).
What should I do if I have a recalled American Regent, Inc. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new American Regent, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.