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Ascend Laboratories, LLC FDA Recalls
39 recalls on file across drugs, 0 of them Class I and 28 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured byClass IIIJul 16, 2026Failed impurity/degradation specification: an OOS result obs |
| Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured bClass IIIJul 16, 2026Failed impurity/degradation specification: an OOS result obs |
| Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured Class IIIJul 16, 2026Failed impurity/degradation specification: an OOS result obs |
| Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem LaboratClass IIJul 8, 2026Failed Dissolution Specifications; Olmesartan Medoxomil cont |
| Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDClass IIIJun 30, 2026Failed Impurities/Degradation Specifications: OOS result was |
| Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDClass IIIJun 30, 2026Failed Impurities/Degradation Specifications: OOS result was |
| Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem LaboraClass IIJun 1, 2026Failed Dissolution Specifications: An out-of-specification ( |
| Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories LtdClass IIMay 5, 2026Failed Dissolution Specifications: Olmesartan Medoxomil cont |
| Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem LabClass IIApr 27, 2026Failed Dissolution Specifications |
| Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c).Class IISep 19, 2025Failed Dissolution Specifications |
| Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), ManufClass IISep 19, 2025Failed Dissolution Specifications |
| Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), cClass IISep 19, 2025Failed Dissolution Specifications |
| Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-Class IISep 19, 2025Failed Dissolution Specifications |
| Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; DistributeClass IIAug 28, 2025Superpotent drug |
| Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Class IIJul 21, 2025Failed Dissolution Specifications: low dissolution results |
| Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., Class IIJul 9, 2025CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan |
| Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,Class IIJul 9, 2025CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan |
| Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Class IIMay 23, 2025Failed Impurities/Degradation Specifications An out-of-speci |
| Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Class IIMay 23, 2025Failed Impurities/Degradation Specifications An out-of-speci |
| Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, DistriClass IIDec 12, 2024CGMP Deviations: Presence of N-nitroso-Dabigatran impurity a |
| Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, DistriClass IIDec 12, 2024CGMP Deviations: Presence of N-nitroso-Dabigatran impurity a |
| Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem LaboratoriClass IISep 3, 2024Failed Dissolution Specifications |
| Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Class IIJan 16, 2024Failed Impurities/Degradation Specification: Out of specific |
| Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd.,Class IIDec 29, 2023Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesyl |
| Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem LaboratorieClass IIIJul 18, 2023Failed Impurities/Degradation Specifications: Out-of-specifi |
| Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Class IIJul 11, 2023Failed Dissolution Specifications |
| Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIAClass IIMar 17, 2023Out of specification (OOS) for Spectroscopic Identification |
| Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Class IIMar 14, 2023CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) im |
| Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd.,Class IIMar 14, 2023CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) im |
| Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem LaboraClass IIJan 5, 2023Failed Dissolution Specification |
| Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem LaborClass IIJan 5, 2023Failed Dissolution Specification |
| Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem LaborClass IIJan 5, 2023Failed Dissolution Specification |
| Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem LaboratoriClass IIDec 28, 2022Presence of Foreign Substance- A complaint was received of b |
| Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem LaborClass IIJan 12, 2022Failed Dissolution Specifications. |
| Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, DistributClass IIDec 21, 2021Failed impurities/degradation specifications |
| Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, IndiClass IINov 3, 2021Failed Impurities/Degradation Specifications |
| Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. Class IIIApr 29, 2021Presence of Foreign Tablet/Capsule |
| Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, LtClass IIJan 22, 2021CGMP Deviations: Individual Unidentified impurities results |
| Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, LClass IIJan 22, 2021CGMP Deviations: Individual Unidentified impurities results |