Ascend Laboratories recalls
Ascend Laboratories appears in 50 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 50 |
|---|---|
| Published | 2016-12-07 to 2026-08-05 |
| By agency | FDA Drug (50) |
| By classification | Class II (41), Class III (9) |
| By status | ongoing (28), terminated (22) |
| Distribution named in notices | AL, CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, PR, RI, SC, TN, TX, US, WA, WI |
Recalls
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laborator…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories
Reason: 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 - Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories
Reason: 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 - Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratori…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories
Reason: 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 - Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2026-07-29 · Ascend Laboratories
Reason: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications - Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…
FDA Drug · Class III · 2026-07-29 · Ascend Laboratories
Reason: 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. - Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…
FDA Drug · Class III · 2026-07-29 · Ascend Laboratories
Reason: 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. - Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA.…
FDA Drug · Class II · 2026-06-17 · Ascend Laboratories
Reason: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis - Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distribut…
FDA Drug · Class II · 2026-06-10 · Ascend Laboratories
Reason: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications - Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., Ind…
FDA Drug · Class II · 2026-05-20 · Ascend Laboratories
Reason: Failed Dissolution Specifications - 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 67…
FDA Drug · Class II · 2025-10-22 · Ascend Laboratories
Reason: Failed Dissolution Specifications - 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-c…
FDA Drug · Class II · 2025-10-22 · Ascend Laboratories
Reason: Failed Dissolution Specifications - 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 6787…
FDA Drug · Class II · 2025-10-22 · Ascend Laboratories
Reason: Failed Dissolution Specifications - 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 L…
FDA Drug · Class II · 2025-10-22 · Ascend Laboratories
Reason: Failed Dissolution Specifications - Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA
FDA Drug · Class II · 2025-09-24 · Ascend Laboratories
Reason: Superpotent drug - Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2025-08-20 · Ascend Laboratories
Reason: Failed Dissolution Specifications: low dissolution results - Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed…
FDA Drug · Class II · 2025-07-23 · Ascend Laboratories
Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. - Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed…
FDA Drug · Class II · 2025-07-23 · Ascend Laboratories
Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. - Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distri…
FDA Drug · Class II · 2025-06-18 · Ascend Laboratories
Reason: 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 Gl… - Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distri…
FDA Drug · Class II · 2025-06-18 · Ascend Laboratories
Reason: 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 Gl… - Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend La…
FDA Drug · Class II · 2024-12-18 · Ascend Laboratories
Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit - Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend La…
FDA Drug · Class II · 2024-12-18 · Ascend Laboratories
Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit - Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA
FDA Drug · Class II · 2024-10-02 · Ascend Laboratories
Reason: Failed Dissolution Specifications - Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Al…
FDA Drug · Class II · 2024-02-28 · Ascend Laboratories
Reason: Failed Impurities/Degradation Specification: Out of specification for organic impurities - Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed…
FDA Drug · Class II · 2024-01-24 · Ascend Laboratories
Reason: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine. - Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Dist…
FDA Drug · Class III · 2023-09-13 · Ascend Laboratories
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability. - Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2023-07-26 · Ascend Laboratories
Reason: Failed Dissolution Specifications - Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Asc…
FDA Drug · Class II · 2023-04-26 · Ascend Laboratories
Reason: Out of specification (OOS) for Spectroscopic Identification test by IR. - Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Asc…
FDA Drug · Class II · 2023-04-05 · Ascend Laboratories
Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. - Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed…
FDA Drug · Class II · 2023-04-05 · Ascend Laboratories
Reason: CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. - Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai…
FDA Drug · Class II · 2023-02-01 · Ascend Laboratories
Reason: Failed Dissolution Specification - Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai…
FDA Drug · Class II · 2023-02-01 · Ascend Laboratories
Reason: Failed Dissolution Specification - Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai…
FDA Drug · Class II · 2023-02-01 · Ascend Laboratories
Reason: Failed Dissolution Specification - Rasagiline Mesylate Tablets 1 mg
FDA Drug · Class II · 2023-01-25 · Ascend Laboratories
Reason: Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets. - Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumba…
FDA Drug · Class II · 2022-02-02 · Ascend Laboratories
Reason: Failed Dissolution Specifications. - Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Labor…
FDA Drug · Class II · 2022-01-12 · Ascend Laboratories
Reason: Failed impurities/degradation specifications - Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by:…
FDA Drug · Class II · 2021-11-17 · Ascend Laboratories
Reason: Failed Impurities/Degradation Specifications - Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013
FDA Drug · Class III · 2021-06-02 · Ascend Laboratories
Reason: Presence of Foreign Tablet/Capsule - Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013…
FDA Drug · Class II · 2021-02-24 · Ascend Laboratories
Reason: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. - Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013…
FDA Drug · Class II · 2021-02-24 · Ascend Laboratories
Reason: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. - Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88
FDA Drug · Class II · 2021-01-13 · Ascend Laboratories
Reason: Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL. - Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratorie…
FDA Drug · Class II · 2021-01-06 · Ascend Laboratories
Reason: Failed Impurity/Degradation Specifications - Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratorie…
FDA Drug · Class II · 2021-01-06 · Ascend Laboratories
Reason: Failed Impurity/Degradation Specifications - Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed…
FDA Drug · Class II · 2020-12-09 · Ascend Laboratories
Reason: Failed Dissolution Specifications; Out of Specification (low) results were obtained. - Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distr…
FDA Drug · Class II · 2020-02-12 · Ascend Laboratories
Reason: cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. - Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumba…
FDA Drug · Class III · 2020-02-12 · Ascend Laboratories
Reason: Failed Dissolution Specifications: low out of specification results for dissolution testing. - Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured…
FDA Drug · Class II · 2019-07-31 · Ascend Laboratories
Reason: Failed Dissolution Specifications - Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, IND…
FDA Drug · Class II · 2019-03-13 · Ascend Laboratories
Reason: Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. - Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India
FDA Drug · Class II · 2018-12-05 · Ascend Laboratories
Reason: Presence of Foreign Substance; metal shard found in tablet - AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Dist…
FDA Drug · Class III · 2017-09-20 · Ascend Laboratories
Reason: 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. - Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distr…
FDA Drug · Class II · 2016-12-07 · Ascend Laboratories
Reason: Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP