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All Recalls

Every Ascend Laboratories, Llc Recall

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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 Drugs·0 affected·Sep 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 Drugs·0 affected·Sep 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 Drugs·141,984 affected·Sep 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 Drugs·0 affected·Sep 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 Drugs·2,256 affected·Aug 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 Drugs·8,568 affected·Jul 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 Drugs·0 affected·Jul 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 Drugs·0 affected·Jul 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 Drugs·10,620 affected·May 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 Drugs·48,936 affected·May 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 Drugs·10,444 affected·Dec 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 Drugs·1,971 affected·Dec 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 Drugs·117,493 affected·Sep 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 Drugs·71,244 affected·Jan 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 Drugs·3,288 affected·Dec 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 Drugs·99,516 affected·Jul 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 Drugs·2,652 affected·Jul 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 Drugs·135 affected·Mar 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 Drugs·12,804 affected·Mar 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 Drugs·13,560 affected·Mar 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 Drugs·49,632 affected·Jan 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 Drugs·6,336 affected·Jan 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 Drugs·2,628 affected·Jan 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 Drugs·12,192 affected·Dec 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 Drugs·9,216 affected·Jan 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 Drugs·42,698 affected·Dec 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 Drugs·4,104 affected·Nov 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 Drugs·34,296 affected·Apr 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 Drugs·14,205 affected·Jan 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 Drugs·23,436 affected·Jan 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 Drugs·9,524 affected·Dec 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 Drugs·29,317 affected·Dec 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 Drugs·1,200 affected·Nov 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 Drugs·20,232 affected·Nov 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 Drugs·192 affected·Jan 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 Drugs·4,728 affected·Jan 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 Drugs·5,472 affected·Jul 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 Drugs·3,072 affected·Feb 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 Drugs·0 affected·Nov 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 Drugs·1,212 affected·May 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 Drugs·1,739 affected·Nov 2, 2016