The Recall Desk

Manufacturer

Ascend Laboratories, LLC

50 recalls in our database name Ascend Laboratories, LLC as the manufacturing or recalling firm.

What the numbers show

Total
50
Critical
0
Severe
2
Most recent
2026-08-05

Of the 50 recalls from Ascend Laboratories, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 50

  • LowFDA (Drugs)·D-0739-2026·2026-08-05

    Dabigatran Etexilate Capsules Recalled Over Impurity Specification Failure

    Ascend Laboratories is recalling dabigatran etexilate capsules due to an out-of-specification result in related substance testing involving Impurity II, Impurity III, and total impurities observed during 12-month stability testing.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0737-2026·2026-08-05

    Dabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure

    Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (150 mg) because testing showed impurities exceeded established limits during stability testing.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0738-2026·2026-08-05

    Dabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure

    Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (75 mg) because testing showed impurities exceeded established limits during stability testing.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0712-2026·2026-07-29

    FDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test

    Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0735-2026·2026-07-29

    Dabigatran Etexilate Capsules Recalled Over Impurity Test Failure

    Ascend Laboratories is recalling 1,753 cartons of dabigatran etexilate capsules (lot 25141707) due to out-of-specification results in impurity testing during 12-month stability studies.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0736-2026·2026-07-29

    Drug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories

    Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0597-2026·2026-06-17

    Minocycline extended-release tablets failed dissolution testing during stability analysis

    Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, are being recalled after an out-of-specification dissolution result at the ninth month of testing. 360 bottles affected.

    Product
    MINOCYCLINE HYDROCHLORIDE — MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0556-2026·2026-06-10

    Ascend amlodipine and olmesartan tablets failed dissolution specifications

    Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, are being recalled after failing dissolution specifications, with olmesartan medoxomil content below specification.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0547-2026·2026-05-20

    Metoprolol Succinate Extended-Release Tablets Recalled Due to Failed Dissolution

    Ascend Laboratories is recalling 17,304 bottles of Metoprolol Succinate Extended-Release 25 mg tablets (Lot #25140859, expiring Jan 2027) distributed nationwide because the tablets failed dissolution specifications, which may affect drug effectiveness.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2025·2025-09-24

    Aripiprazole 10 mg tablets recalled after testing superpotent in one lot

    Aripiprazole Tablets, USP, 10 mg, lot 24144162, distributed by Ascend Laboratories, are recalled nationwide as a superpotent drug. 2,256 bottles are affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0576-2025·2025-08-20

    Amlodipine and olmesartan tablets recalled after failing dissolution specification testing

    Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2025·2025-07-23

    Rizatriptan 10 mg tablets exceed the acceptable intake limit for nitrosamine

    Rizatriptan Benzoate Tablets USP 10 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0533-2025·2025-07-23

    Rizatriptan 5 mg tablets exceed the acceptable intake limit for nitrosamine

    Rizatriptan Benzoate Tablets USP 5 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0468-2025·2025-06-18

    Cephalexin Oral Suspension Recalled for Failed Impurity Specifications

    Ascend Laboratories is recalling Cephalexin for Oral Suspension due to failed impurity specifications identified during stability testing. An out-of-specification result for Cephalexin Glucose Adduct was observed at six months.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2025·2025-06-18

    Cephalexin Oral Suspension Recalled for Failed Impurities Specifications

    Ascend Laboratories is recalling Cephalexin for Oral Suspension due to an out-of-specification result in impurity testing that identified Cephalexin Glucose Adduct during stability analysis.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2025·2024-12-18

    Dabigatran Etexilate 75 mg capsules recalled for N-nitroso impurity

    Ascend Laboratories is recalling Dabigatran Etexilate 75 mg capsules nationwide due to manufacturing deviations. Three lots contain N-nitroso-Dabigatran impurity above recommended interim limits.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2025·2024-12-18

    Prescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity

    Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2024·2024-10-02

    Prescription immunosuppressant tablets recalled due to failed dissolution specifications

    Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.

    Product
    MYCOPHENOLIC ACID — MYCOPHENOLIC ACID (MYCOPHENOLIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0339-2024·2024-02-28

    Fosfomycin Tromethamine Granules Recalled for Out-of-Specification Organic Impurities

    Ascend Laboratories recalls 71,244 sachets of Fosfomycin Tromethamine for failing quality specifications due to organic impurities. Patients with affected lots should consult their healthcare provider.

    Product
    FOSFOMYCIN TROMETHAMINE — FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0237-2024·2024-01-24

    Ibuprofen and Famotidine Tablets Recalled for Foreign Tablet Contamination

    Ascend Laboratories is recalling 3,288 bottles of Ibuprofen and Famotidine tablets nationwide because a stray Rasagiline Mesylate tablet was discovered in an unopened bottle during quality control.

    Product
    IBUPROFEN AND FAMOTIDINE — IBUPROFEN AND FAMOTIDINE (IBUPROFEN AND FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1145-2023·2023-09-13

    Fosfomycin Tromethamine Antibiotic Recalled for Failed Stability Specifications

    Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.

    Product
    FOSFOMYCIN TROMETHAMINE — FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide