Ascend Laboratories, LLC
Complete recall history across all FDA and CPSC categories — 26 total recalls
Ascend Laboratories, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (26)
FDA drug safety enforcement actions by Ascend Laboratories, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| May 5, 2026 | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bott... | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifi... | Class II |
| Apr 27, 2026 | Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP,... | Failed Dissolution Specifications | Class II |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-51... | Failed Dissolution Specifications | Class II |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 6787... | Failed Dissolution Specifications | Class II |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-... | Failed Dissolution Specifications | Class II |
| Sep 19, 2025 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-... | Failed Dissolution Specifications | Class II |
| Aug 28, 2025 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by:... | Superpotent drug | Class II |
| Jul 21, 2025 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx... | Failed Dissolution Specifications: low dissolution results | Class II |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above ... | Class II |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above ... | Class II |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result w... | Class II |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result w... | Class II |
| Dec 12, 2024 | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured... | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended ... | Class II |
| Dec 12, 2024 | Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured... | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended ... | Class II |
| Sep 3, 2024 | Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets p... | Failed Dissolution Specifications | Class II |
| Jan 16, 2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of... | Failed Impurities/Degradation Specification: Out of specification for organic... | Class II |
| Dec 29, 2023 | Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle... | Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet w... | Class II |
| Jul 18, 2023 | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... | Failed Impurities/Degradation Specifications: Out-of-specification results ob... | Class III |
| Jul 11, 2023 | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem... | Failed Dissolution Specifications | Class II |
| Mar 17, 2023 | Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manuf... | Out of specification (OOS) for Spectroscopic Identification test by IR. | Class II |
| Mar 14, 2023 | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufa... | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels abo... | Class II |
| Mar 14, 2023 | Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,... | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels abo... | Class II |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... | Failed Dissolution Specification | Class II |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II |
| Dec 28, 2022 | Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 678... | Presence of Foreign Substance- A complaint was received of black spots/shiny ... | Class II |
| Jan 12, 2022 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table... | Failed Dissolution Specifications. | Class II |
| Dec 21, 2021 | Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem ... | Failed impurities/degradation specifications | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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