Manufacturer profile
Amneal Pharmaceuticals LLC
Pharmaceutical company8 products tracked
8
products tracked
165,802
total reports
23
recalls on record
86.6%
serious overall
Products
showing 8 of 8
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1990 | 54,798 | Colitis ulcerative | 10 | |
| 2004 | 36,718 | Malignant neoplasm progression | 1 | |
| 2004 | 36,708 | Malignant neoplasm progression | 0 | |
| — | 12,505 | Macular degeneration | 4 | |
| 2005 | 11,390 | Hepatitis b dna increased | 6 | |
| 2008 | 10,727 | Urinary retention | 2 | |
| — | 1,713 | Upper airway obstruction | 0 | |
| 1984 | 1,243 | Sedation complication | 0 |
Recall history · 20 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Dec 16, 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| Oct 10, 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| Sep 24, 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| Sep 24, 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| Sep 4, 2025 | II | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc |
| Sep 4, 2025 | II | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc |
| Feb 5, 2024 | II | Failed Dissolution Specifications: Out of specification for dissolution. | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | II | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 30, 2020 | II | Failed Dissolution Specifications | AVKARE Inc. |
| Oct 28, 2020 | II | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. | Teva Pharmaceuticals USA |
| Feb 20, 2020 | II | Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. | Teva Pharmaceuticals USA |
| Jun 12, 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| Jul 20, 2017 | II | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point. | Hetero USA Inc |
| Dec 12, 2016 | II | Failed Dissolution Specifications | Amneal Pharmaceuticals LLC |
| Dec 2, 2016 | III | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules | Shire PLC |
| May 20, 2014 | II | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. | Cambrex Charles City Inc |
| Jul 2, 2013 | II | Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014. | Aidapak Services, LLC |
| Jul 2, 2013 | II | Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014. | Aidapak Services, LLC |
| Jul 2, 2013 | II | Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014. | Aidapak Services, LLC |
| Jul 2, 2013 | II | Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014. | Aidapak Services, LLC |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Amneal Pharmaceuticals LLC 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.