--- title: "Ascend Laboratories LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Ascend Laboratories LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/ascend-laboratories-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Ascend Laboratories LLC recall records **28** reported ongoing 36 records in this archive. Latest source date Jul 16, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 16, 2026 FDA drug enforcement ### [Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed b...](https://isitonrecall.com/recall/fda-drug-d-0737-2026-dabigatran-etexilate-capsules-150-mg-60-count-6x10-blister-pack-further-packaged-in-a-carton-rx-only/) Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability Class III Reported ongoing Distribution: USA Nationwide [Official source for Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0737-2026%22) Jul 16, 2026 FDA drug enforcement ### [Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by:...](https://isitonrecall.com/recall/fda-drug-d-0738-2026-dabigatran-etexilate-capsules-75-mg-60-count-6x10-blister-pack-further-packaged-in-a-carton-rx-only/) Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability Class III Reported ongoing Distribution: USA Nationwide [Official source for Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, R...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0738-2026%22) Jul 16, 2026 FDA drug enforcement ### [Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by...](https://isitonrecall.com/recall/fda-drug-d-0739-2026-dabigatran-etexilate-capsules-75-mg-30-count-3x10-blister-pack-further-packaged-in-a-carton-rx-only/) Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability Class III Reported ongoing Distribution: USA Nationwide [Official source for Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0739-2026%22) Jul 8, 2026 FDA drug enforcement ### [Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, L...](https://isitonrecall.com/recall/fda-drug-d-0712-2026-amlodipine-and-olmesartan-medoxomil-tablets-10-mg-20-mg-30-tablets-per-bottle-rx-only-manufactured-b/) Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0712-2026%22) Jun 30, 2026 FDA drug enforcement ### [Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, ...](https://isitonrecall.com/recall/fda-drug-d-0735-2026-dabigatran-etexilate-capsules-110-mg-60-count-carton-6x10-rx-only-manufactured-by-alkem-laboratories/) Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. Class III Reported ongoing Distribution: USA Nationwide [Official source for Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem La...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0735-2026%22) Jun 30, 2026 FDA drug enforcement ### [Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, ...](https://isitonrecall.com/recall/fda-drug-d-0736-2026-dabigatran-etexilate-capsules-150-mg-20-count-carton-2x10-rx-only-manufactured-by-alkem-laboratories/) Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. Class III Reported ongoing Distribution: USA Nationwide [Official source for Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem La...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0736-2026%22) Jun 1, 2026 FDA drug enforcement ### [Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, ...](https://isitonrecall.com/recall/fda-drug-d-0597-2026-minocycline-hydrochloride-extended-release-tablets-usp-115-mg-30-count-bottle-rx-only-manufactured-b/) Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0597-2026%22) May 5, 2026 FDA drug enforcement ### [Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Pars...](https://isitonrecall.com/recall/fda-drug-d-0556-2026-amlodipine-and-olmesartan-medoxomil-tablets-5mg-40mg-rx-only-30-count-bottle-manufactured-by-alkem-l/) Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications Class II Reported ongoing Distribution: U.S.A. Nationwide [Official source for Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by:...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0556-2026%22) Apr 27, 2026 FDA drug enforcement ### [Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg\* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratorie...](https://isitonrecall.com/recall/fda-drug-d-0547-2026-ascend-laboratories-llc-metoprolol-succinate-extended-release-tablets-usp-25-mg-rx-only-manufactured/) Failed Dissolution Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg\* Rx Only, Man...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0547-2026%22) Sep 19, 2025 FDA drug enforcement ### [Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufac...](https://isitonrecall.com/recall/fda-drug-d-0017-2026-atorvastatin-calcium-tablets-usp-10-mg-rx-only-a-90-count-bottle-ndc-67877-511-90-b-500-count-bottle/) Failed Dissolution Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-c...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0017-2026%22) Sep 19, 2025 FDA drug enforcement ### [Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem La...](https://isitonrecall.com/recall/fda-drug-d-0018-2026-atorvastatin-calcium-tablets-usp-40-mg-rx-only-a-90-count-ndc-67877-513-90-b-500-count-ndc-67877-513/) Failed Dissolution Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0018-2026%22) Sep 19, 2025 FDA drug enforcement ### [Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Labor...](https://isitonrecall.com/recall/fda-drug-d-0019-2026-atorvastatin-calcium-tablets-usp-20-mg-rx-only-a-90-count-ndc-67877-512-90-b-500-count-ndc-67877-512/) Failed Dissolution Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0019-2026%22) Sep 19, 2025 FDA drug enforcement ### [Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed b...](https://isitonrecall.com/recall/fda-drug-d-0020-2026-atorvastatin-calcium-tablets-usp-80-mg-rx-only-a-90-count-ndc-67877-514-90-b-500-count-ndc-67877-514/) Failed Dissolution Specifications Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(N...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0020-2026%22) Aug 28, 2025 FDA drug enforcement ### [Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC...](https://isitonrecall.com/recall/fda-drug-d-0645-2025-aripiprazole-tablets-usp-10-mg-30-count-bottles-rx-only-manufactured-by-alken-laboratories-ltd-india/) Superpotent drug Class II Reported ongoing Distribution: Nationwide in the USA. [Official source for Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0645-2025%22) Jul 21, 2025 FDA drug enforcement ### [Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Pa...](https://isitonrecall.com/recall/fda-drug-d-0576-2025-amlodipine-and-olmesartan-medoxomil-tablets-5-mg-40-mg-30-count-bottle-rx-only-manufactured-by-alkem/) Failed Dissolution Specifications: low dissolution results Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0576-2025%22) Jul 9, 2025 FDA drug enforcement ### [Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippan...](https://isitonrecall.com/recall/fda-drug-d-0533-2025-rizatriptan-benzoate-tablets-usp-5-mg-18-3x6-unit-dose-tablets-rx-only-manufactured-by-alkem-laborat/) CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. Class II Reported ongoing Distribution: US Nationwide. [Official source for Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Al...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0533-2025%22) Jul 9, 2025 FDA drug enforcement ### [Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippa...](https://isitonrecall.com/recall/fda-drug-d-0534-2025-rizatriptan-benzoate-tablets-usp-10-mg-18-3x6-unit-dose-tablets-rx-only-manufactured-by-alkem-labora/) CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. Class II Reported ongoing Distribution: US Nationwide. [Official source for Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: A...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0534-2025%22) May 23, 2025 FDA drug enforcement ### [Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Pa...](https://isitonrecall.com/recall/fda-drug-d-0468-2025-cephalexin-for-oral-suspension-usp-125-mg-per-5-ml-100-ml-when-mixed-rx-only-manufactured-by-alkem-l/) Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. Class II Reported ongoing Distribution: Nationwide in the USA. [Official source for Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0468-2025%22) May 23, 2025 FDA drug enforcement ### [Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Pa...](https://isitonrecall.com/recall/fda-drug-d-0469-2025-cephalexin-for-oral-suspension-usp-125-mg-per-5-ml-200-ml-when-mixed-rx-only-manufactured-by-alkem-l/) Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct. Class II Reported ongoing Distribution: Nationwide in the USA. [Official source for Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0469-2025%22) Dec 12, 2024 FDA drug enforcement ### [Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 N...](https://isitonrecall.com/recall/fda-drug-d-0129-2025-dabigatran-etexilate-75-mg-capsules-60-count-bottles-rx-only-manufactured-by-alkem-laboratories-ltd/) CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laborator...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0129-2025%22) ## Reasons in these listed records - Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability - Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications - Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability. - Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis These examples come from this result page and are not a ranking of every recall reason. ## Checking Ascend Laboratories LLC ### Is there a recall on ascend laboratories llc right now? This archive contains 36 records, including 28 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Ascend Laboratories LLC](https://isitonrecall.com/check/?q=Ascend%20Laboratories%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)