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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.
February 1, 2023DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labora
Hazard: Failed Dissolution Specification
February 1, 2023DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specification
January 25, 2023DrugsFDA
Ascend Laboratories, LLC recalls Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratori
Hazard: Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
February 2, 2022DrugsFDA
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specifications.
January 12, 2022DrugsFDA
Ascend Laboratories, LLC recalls Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distribut
Hazard: Failed impurities/degradation specifications
November 17, 2021DrugsFDA
Ascend Laboratories LLC recalls Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, Indi
Hazard: Failed Impurities/Degradation Specifications
June 2, 2021DrugsFDA
Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013.
Hazard: Presence of Foreign Tablet/Capsule
February 24, 2021DrugsFDA
Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Lt
Hazard: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
February 24, 2021DrugsFDA
Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, L
Hazard: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
January 13, 2021DrugsFDA
Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 20
Hazard: Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
January 6, 2021DrugsFDA
Ascend Laboratories LLC recalls Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by
Hazard: Failed Impurity/Degradation Specifications
January 6, 2021DrugsFDA
Ascend Laboratories LLC recalls Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by
Hazard: Failed Impurity/Degradation Specifications
December 9, 2020DrugsFDA
Ascend Laboratories LLC recalls Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013,
Hazard: Failed Dissolution Specifications; Out of Specification (low) results were obtained.
February 12, 2020DrugsFDA
Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4
Hazard: cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
February 12, 2020DrugsFDA
Ascend Laboratories LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Labor
Hazard: Failed Dissolution Specifications: low out of specification results for dissolution testing.
July 31, 2019DrugsFDA
Ascend Laboratories LLC recalls Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx
Hazard: Failed Dissolution Specifications
March 13, 2019DrugsFDA
Ascend Laboratories LLC recalls Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mu
Hazard: Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
December 5, 2018DrugsFDA
Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,
Hazard: Presence of Foreign Substance; metal shard found in tablet
September 20, 2017DrugsFDA
Ascend Laboratories LLC recalls AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4
Hazard: PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
December 7, 2016DrugsFDA
Ascend Laboratories LLC recalls Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai -
Hazard: Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP