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Ascend Laboratories, LLC
Ascend Laboratories, LLC: 45 FDA recall reports
Every drug recall the FDA has published for Ascend Laboratories, LLC. The fault, and how the agency graded it.
45Reports
0Class I
23Ongoing
2026-07-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alk
D-0712-2026 · Class II · reported 2026-07-29 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
- Where it went
- Nationwide in the USA
- How much
- 6,192 bottles
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Al
D-0597-2026 · Class II · reported 2026-06-17 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- Product
- Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
- Where it went
- Nationwide in the USA
- How much
- 360 30-count bottles
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Labora
D-0556-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
- Where it went
- U.S.A. Nationwide
- How much
- 15,696 x 30's bottles
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by:
D-0547-2026 · Class II · reported 2026-05-20 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
- Where it went
- U.S. Nationwide
- How much
- 17,304 100-count bottles
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-
D-0020-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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 Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
- Where it went
- U.S. Nationwide
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-51
D-0019-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- U.S. Nationwide
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (
D-0017-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- U.S. Nationwide
- How much
- 141,984 bottles
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-
D-0018-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Where it went
- U.S. Nationwide
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA;
D-0645-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Superpotent drug
- Product
- Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
- Where it went
- Nationwide in the USA.
- How much
- 2,256 bottles
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Lab
D-0576-2025 · Class II · reported 2025-08-20 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications: low dissolution results
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
- Where it went
- Nationwide in the USA
- How much
- 8,568 bottles
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laborato
D-0534-2025 · Class II · reported 2025-07-23 · Ongoing
- Why it was recalled
- CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
- Product
- Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
- Where it went
- US Nationwide.
- How much
- N/A
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laborator
D-0533-2025 · Class II · reported 2025-07-23 · Ongoing
- Why it was recalled
- CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
- Product
- Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
- Where it went
- US Nationwide.
- How much
- N/A
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Lab
D-0469-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- 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 Glucose Adduct.
- Product
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
- Where it went
- Nationwide in the USA.
- How much
- 10,620 - 200 mL bottles
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Lab
D-0468-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- 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 Glucose Adduct.
- Product
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
- Where it went
- Nationwide in the USA.
- How much
- 48,936 - 100 mL bottles
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., IND
D-0130-2025 · Class II · reported 2024-12-18 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- Product
- Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60
- Where it went
- Nationwide within the United States
- How much
- 10,444 bottles
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., IND
D-0129-2025 · Class II · reported 2024-12-18 · Ongoing
- Why it was recalled
- CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- Product
- Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
- Where it went
- Nationwide within the United States
- How much
- 1971 bottles
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem
D-0668-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
- Where it went
- Nationwide in the USA and PR
- How much
- 117,493 bottles
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet,
D-0339-2024 · Class II · reported 2024-02-28 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specification: Out of specification for organic impurities
- Product
- Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
- Where it went
- Nationwide in the USA
- How much
- 71,244 sachets
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laborato
D-0237-2024 · Class II · reported 2024-01-24 · Ongoing
- Why it was recalled
- Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
- Product
- Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
- Where it went
- Nationwide
- How much
- 3,288 bottles
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem L
D-1145-2023 · Class III · reported 2023-09-13 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
- Product
- Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
- Where it went
- The recall product was distributed nationwide.
- How much
- 99,516 sachets
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distri
D-0925-2023 · Class II · reported 2023-07-26 · Ongoing
- Why it was recalled
- Failed Dissolution Specifications
- Product
- Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
- Where it went
- Nationwide in the USA
- How much
- 2652 bottles
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories L
D-0539-2023 · Class II · reported 2023-04-26 · Ongoing
- Why it was recalled
- Out of specification (OOS) for Spectroscopic Identification test by IR.
- Product
- Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
- Where it went
- Nationwide in the USA
- How much
- 135 bottles
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laborato
D-0534-2023 · Class II · reported 2023-04-05 · Ongoing
- Why it was recalled
- CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
- Product
- Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.
- Where it went
- Nationwide in the USA.
- How much
- 12,804 bottles
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd
D-0533-2023 · Class II · reported 2023-04-05 · Ongoing
- Why it was recalled
- CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
- Product
- Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.
- Where it went
- Nationwide in the USA.
- How much
- 13,560 bottles
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: A
D-0169-2023 · Class II · reported 2023-02-01 · Terminated
- Why it was recalled
- Failed Dissolution Specification
- Product
- Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.
- Where it went
- Nationwide and Puerto Rico
- How much
- 49,632 bottles
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Al
D-0170-2023 · Class II · reported 2023-02-01 · Terminated
- Why it was recalled
- Failed Dissolution Specification
- Product
- Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.
- Where it went
- Nationwide and Puerto Rico
- How much
- 6,336 bottles
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: A
D-0171-2023 · Class II · reported 2023-02-01 · Terminated
- Why it was recalled
- Failed Dissolution Specification
- Product
- Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.
- Where it went
- Nationwide and Puerto Rico
- How much
- 2628 bottles
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem
D-0159-2023 · Class II · reported 2023-01-25 · Terminated
- Why it was recalled
- Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
- Product
- Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
- Where it went
- Customers in 19 states: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, RI, TN, TX, WA, WI; Puerto Rico
- How much
- 12192 bottles
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: A
D-0393-2022 · Class II · reported 2022-02-02 · Terminated
- Why it was recalled
- Failed Dissolution Specifications.
- Product
- Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
- Where it went
- Nationwide in the USA
- How much
- 9216 bottles
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India,
D-0359-2022 · Class II · reported 2022-01-12 · Terminated
- Why it was recalled
- Failed impurities/degradation specifications
- Product
- Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
- Where it went
- USA nationwide.
- How much
- 42,698 bottles
Showing the 30 most recent of 45. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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