Ascend Laboratories LLC
Ascend Laboratories LLC appears in FDA public data with 50 recalls, 0 510(k) clearances, 5 FDA inspections, and 2 compliance actions on record. Its most recent recall (D-0737-2026, Class III) was initiated on July 16, 2026.
Summary
- Total Recalls
- 50
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0737-2026 | Class III | Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx | July 16, 2026 |
| D-0739-2026 | Class III | Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx | July 16, 2026 |
| D-0738-2026 | Class III | Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx o | July 16, 2026 |
| D-0712-2026 | Class II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactur | July 8, 2026 |
| D-0735-2026 | Class III | Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Labor | June 30, 2026 |
| D-0736-2026 | Class III | Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Labor | June 30, 2026 |
| D-0597-2026 | Class II | Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactu | June 1, 2026 |
| D-0556-2026 | Class II | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Al | May 5, 2026 |
| D-0547-2026 | Class II | Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufa | April 27, 2026 |
| D-0017-2026 | Class II | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-coun | September 19, 2025 |
| D-0018-2026 | Class II | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count ( | September 19, 2025 |
| D-0019-2026 | Class II | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (ND | September 19, 2025 |
| D-0020-2026 | Class II | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC | September 19, 2025 |
| D-0645-2025 | Class II | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd | August 28, 2025 |
| D-0576-2025 | Class II | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: | July 21, 2025 |
| D-0534-2025 | Class II | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alke | July 9, 2025 |
| D-0533-2025 | Class II | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem | July 9, 2025 |
| D-0468-2025 | Class II | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: | May 23, 2025 |
| D-0469-2025 | Class II | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: | May 23, 2025 |
| D-0129-2025 | Class II | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories | December 12, 2024 |