Ascend Laboratories recalls
FDA enforcement reports naming Ascend Laboratories LLC as the recalling firm.
- Recall reports
- 50
- Class I (serious)
- 0
- Most recent report
- Aug 5, 2026
- Aug 5, 2026Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in…Drug · Ascend Laboratories, LLCFailed 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 stabilityClass III
- Aug 5, 2026Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a…Drug · Ascend Laboratories, LLCFailed 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 stabilityClass III
- Aug 5, 2026Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in…Drug · Ascend Laboratories, LLCFailed 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 stabilityClass III
- Jul 29, 2026Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by…Drug · Ascend Laboratories, LLCFailed 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.Class III
- Jul 29, 2026Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by…Drug · Ascend Laboratories, LLCFailed 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.Class III
- Jul 29, 2026Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Onl…Drug · Ascend Laboratories, LLCFailed Dissolution Specifications; Olmesartan Medoxomil content below specificationsClass II
- Jun 17, 2026Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx On…Drug · Ascend Laboratories, LLCFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysisClass II
- Jun 10, 2026Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufa…Drug · Ascend Laboratories, LLCFailed Dissolution Specifications: Olmesartan Medoxomil content below specificationsClass II
- May 20, 2026Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx…Drug · Ascend Laboratories, LLCFailed Dissolution SpecificationsClass II
- Oct 22, 2025Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a)Drug · Ascend Laboratories, LLCFailed Dissolution SpecificationsClass II
- Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a)
- Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a)
- Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b)
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Lab…
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Man…
- Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufact…
- Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactu…
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Man…
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Man…
- Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem…
- Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem…
- Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle,…
- Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomyci…
- Ibuprofen and Famotidine Tablets 800mg/26
- Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, M…
- Fingolimod Capsules, 0
- Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by…
- Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by:…
- Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactu…
- Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bott…
- Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bott…
- Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bott…
- Rasagiline Mesylate Tablets 1 mg
- Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bot…
- Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratori…
- Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laborato…
- Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem La…
- Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manuf…
- Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufa…
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed…
- Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (wh…
- Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (wh…
- Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Lab…
- Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx O…
- Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Al…
- Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count…
- Tamsulosin Hydrochloride Capsules, USP, 0
- Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Lab…
- AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Al…
- Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Al…
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