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Ascend Laboratories Recalls
50 recalls on record · December 7, 2016 to August 5, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 5, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured b
Hazard: 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
August 5, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by
Hazard: 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
August 5, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured
Hazard: 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
July 29, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, IND
Hazard: 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.
July 29, 2026DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, IND
Hazard: 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.
July 29, 2026DrugsFDA
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laborat
Hazard: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
June 17, 2026DrugsFDA
Ascend Laboratories, LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Labora
Hazard: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
June 10, 2026DrugsFDA
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd
Hazard: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
May 20, 2026DrugsFDA
Ascend Laboratories, LLC recalls Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Lab
Hazard: Failed Dissolution Specifications
October 22, 2025DrugsFDA
Ascend Laboratories, LLC recalls Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manuf
Hazard: Failed Dissolution Specifications
October 22, 2025DrugsFDA
Ascend Laboratories, LLC recalls Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c).
Hazard: Failed Dissolution Specifications
October 22, 2025DrugsFDA
Ascend Laboratories, LLC recalls Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c
Hazard: Failed Dissolution Specifications
October 22, 2025DrugsFDA
Ascend Laboratories, LLC recalls Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-
Hazard: Failed Dissolution Specifications
September 24, 2025DrugsFDA
Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distribute
Hazard: Superpotent drug
August 20, 2025DrugsFDA
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories
Hazard: Failed Dissolution Specifications: low dissolution results
July 23, 2025DrugsFDA
Ascend Laboratories, LLC recalls Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,
Hazard: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
July 23, 2025DrugsFDA
Ascend Laboratories, LLC recalls Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,
Hazard: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
June 18, 2025DrugsFDA
Ascend Laboratories, LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories
Hazard: 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.
June 18, 2025DrugsFDA
Ascend Laboratories, LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories
Hazard: 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.
December 18, 2024DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distri
Hazard: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
December 18, 2024DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distri
Hazard: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
October 2, 2024DrugsFDA
Ascend Laboratories, LLC recalls Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratori
Hazard: Failed Dissolution Specifications
February 28, 2024DrugsFDA
Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,
Hazard: Failed Impurities/Degradation Specification: Out of specification for organic impurities
January 24, 2024DrugsFDA
Ascend Laboratories, LLC recalls Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd.,
Hazard: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
September 13, 2023DrugsFDA
Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratorie
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
July 26, 2023DrugsFDA
Ascend Laboratories, LLC recalls Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by:
Hazard: Failed Dissolution Specifications
April 26, 2023DrugsFDA
Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA
Hazard: Out of specification (OOS) for Spectroscopic Identification test by IR.
April 5, 2023DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd.,
Hazard: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
April 5, 2023DrugsFDA
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA,
Hazard: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
February 1, 2023DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specification