Brand
Ascend Laboratories, Llc Recalls
41 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ascend Laboratories, Llc.
41Total Recalls
0Critical
820,902Units Affected
Sep 19, 2025Most Recent
All Recalls
Every Ascend Laboratories, Llc Recall
Sorted by most recent. Click any recall for full details.
41 recalls
High RiskFDA
Ascend Laboratories, Llc
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...
Oral Drugs0 affectedSep 19, 2025
High RiskFDA
Ascend Laboratories, Llc
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 6...
Oral Drugs0 affectedSep 19, 2025
High RiskFDA
Ascend Laboratories, Llc
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...
Oral Drugs141,984 affectedSep 19, 2025
High RiskFDA
Ascend Laboratories, Llc
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 (ND...
Oral Drugs0 affectedSep 19, 2025
High RiskFDA
Ascend Laboratories, Llc
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Labo...
Oral Drugs2,256 affectedAug 28, 2025
High RiskFDA
Ascend Laboratories, Llc
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Dist...
Oral Drugs8,568 affectedJul 21, 2025
High RiskFDA
Ascend Laboratories, Llc
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribut...
Oral Drugs0 affectedJul 9, 2025
High RiskFDA
Ascend Laboratories, Llc
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribute...
Oral Drugs0 affectedJul 9, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs10,620 affectedMay 23, 2025
High RiskFDA
Ascend Laboratories, Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Dist...
Oral Drugs48,936 affectedMay 23, 2025
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend ...
Oral Drugs10,444 affectedDec 12, 2024
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend ...
Oral Drugs1,971 affectedDec 12, 2024
High RiskFDA
Ascend Laboratories, Llc
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; D...
Oral Drugs117,493 affectedSep 3, 2024
High RiskFDA
Ascend Laboratories, Llc
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: ...
Oral Drugs71,244 affectedJan 16, 2024
High RiskFDA
Ascend Laboratories, Llc
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distribut...
Oral Drugs3,288 affectedDec 29, 2023
RecallFDA
Ascend Laboratories, Llc
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Di...
Oral Drugs99,516 affectedJul 18, 2023
High RiskFDA
Ascend Laboratories, Llc
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratori...
Oral Drugs2,652 affectedJul 11, 2023
High RiskFDA
Ascend Laboratories, Llc
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by:...
Oral Drugs135 affectedMar 17, 2023
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribut...
Oral Drugs12,804 affectedMar 14, 2023
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: A...
Oral Drugs13,560 affectedMar 14, 2023
High RiskFDA
Ascend Laboratories, Llc
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mum...
Oral Drugs49,632 affectedJan 5, 2023
High RiskFDA
Ascend Laboratories, Llc
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumb...
Oral Drugs6,336 affectedJan 5, 2023
High RiskFDA
Ascend Laboratories, Llc
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mum...
Oral Drugs2,628 affectedJan 5, 2023
High RiskFDA
Ascend Laboratories, Llc
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; D...
Oral Drugs12,192 affectedDec 28, 2022
High RiskFDA
Ascend Laboratories, Llc
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mum...
Oral Drugs9,216 affectedJan 12, 2022
High RiskFDA
Ascend Laboratories, Llc
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Lab...
Oral Drugs42,698 affectedDec 21, 2021
High RiskFDA
Ascend Laboratories Llc
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by...
Oral Drugs4,104 affectedNov 3, 2021
RecallFDA
Ascend Laboratories Llc
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distribute...
Oral Drugs34,296 affectedApr 29, 2021
High RiskFDA
Ascend Laboratories Llc
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 0...
Oral Drugs14,205 affectedJan 22, 2021
High RiskFDA
Ascend Laboratories Llc
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 01...
Oral Drugs23,436 affectedJan 22, 2021
High RiskFDA
Ascend Laboratories Llc
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laborator...
Oral Drugs9,524 affectedDec 17, 2020
High RiskFDA
Ascend Laboratories Llc
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laborator...
Oral Drugs29,317 affectedDec 17, 2020
High RiskFDA
Ascend Laboratories Llc
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distribute...
Oral Drugs1,200 affectedNov 24, 2020
High RiskFDA
Ascend Laboratories Llc
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed)...
Oral Drugs20,232 affectedNov 23, 2020
High RiskFDA
Ascend Laboratories Llc
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Dis...
Oral Drugs192 affectedJan 24, 2020
RecallFDA
Ascend Laboratories Llc
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mum...
Oral Drugs4,728 affectedJan 22, 2020
High RiskFDA
Ascend Laboratories Llc
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufacture...
Oral Drugs5,472 affectedJul 19, 2019
High RiskFDA
Ascend Laboratories Llc
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, I...
Oral Drugs3,072 affectedFeb 22, 2019
High RiskFDA
Ascend Laboratories Llc
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distribut...
Oral Drugs0 affectedNov 14, 2018
RecallFDA
Ascend Laboratories Llc
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Di...
Oral Drugs1,212 affectedMay 5, 2017
High RiskFDA
Ascend Laboratories Llc
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, D...
Oral Drugs1,739 affectedNov 2, 2016