Manufacturer profile
American Regent, Inc.
Pharmaceutical company4 products tracked
4
products tracked
19,384
total reports
4
recalls on record
63.4%
serious overall
Products
showing 4 of 4
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1978 | 8,660 | Product deposit | 0 | |
| 2013 | 4,574 | Hypophosphataemia | 1 | |
| — | 4,574 | Hypophosphataemia | 0 | |
| 1986 | 1,576 | Nail bed inflammation | 3 |
Recall history · 11 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Apr 16, 2026 | III | Labeling: Missing Label | American Regent, Inc. |
| Apr 18, 2025 | II | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | American Regent, Inc. |
| Apr 18, 2025 | II | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | American Regent, Inc. |
| Nov 11, 2024 | II | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. |
| Nov 11, 2024 | II | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. |
| Nov 11, 2024 | II | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. |
| May 14, 2024 | II | Lack of Assurance of Sterility. | American Regent, Inc. |
| Jun 18, 2019 | II | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc |
| Jun 12, 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| Feb 24, 2015 | II | Presence of particulate. | SCA Pharmaceuticals |
| Nov 14, 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from American Regent, Inc. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.