Ascend Laboratories, LLC recalls
Every recall we track for Ascend Laboratories, LLC — 50 in all, from 2016–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Ascend Laboratories, LLC more than doubled in 2025 (10, up from 4 in 2024).
All FDA recall records for Ascend Laboratories, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 1 | 0 | 0 | 1 |
| 2019 | 0 | 1 | 1 | 0 | 2 |
| 2020 | 0 | 1 | 2 | 3 | 6 |
| 2021 | 0 | 2 | 1 | 2 | 5 |
| 2022 | 0 | 1 | 1 | 0 | 2 |
| 2023 | 0 | 0 | 5 | 4 | 9 |
| 2024 | 0 | 0 | 1 | 3 | 4 |
| 2025 | 0 | 1 | 4 | 5 | 10 |
| 2026 (to date) | 0 | 0 | 4 | 5 | 9 |
Ascend Laboratories, LLC recalls before 2017
Recalls on record by year.
Most common reasons for Ascend Laboratories, LLC recalls
What to do if you have a recalled Ascend Laboratories, LLC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Ascend Laboratories, LLC recalls
36 shown- UnratedDrug
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured
Ascend Laboratories recalls 75mg Dabigatran Etexilate capsules (NDC 0904-7253-68) due to failed impurity tests. This could affect drug safety for patients using blood thinners.
Ascend LaboratoriesJul 16, 2026 - Lower riskDrug
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem
Ascend Laboratories recalls 10mg/20mg Amlodipine and Olmesartan Medoxomil tablets (NDC 67877-500-30) due to failed dissolution specs causing low drug content. Rx only, manufactured in India, distributed in US.
Ascend LaboratoriesJul 8, 2026 - UnratedDrug
Ascend Laboratories, LLC recalls Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai,
Ascend Laboratories recalls 150mg Dabigatran etexilate capsules (NDC 0904-7255-10) manufactured by Alkem Laboratories in India. The capsules failed impurity tests during stability testing, potentially posing health risks.
Ascend LaboratoriesJun 30, 2026 - Lower riskDrug
Ascend Laboratories, LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem
Ascend Laboratories recalls 115mg Minocycline Hydrochloride Extended-Release Tablets due to failed dissolution test. This may affect medication effectiveness. Check NDC 67877-644-30 and lot numbers for affected products.
Ascend LaboratoriesJun 1, 2026 - Lower riskDrug
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories
Ascend Laboratories recalls 5mg/40mg Amlodipine and Olmesartan Medoxomil tablets (Rx only) manufactured by Alkem Labs in India. The tablets may have lower than expected drug content, potentially reducing effectiveness for blood pressure control.
Ascend LaboratoriesMay 5, 2026 - Lower riskDrug
Ascend Laboratories, LLC recalls Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem
Ascend Laboratories recalls 25mg metoprolol succinate extended-release tablets due to failed dissolution specifications. This may affect medication effectiveness. Contact for remedy details.
Ascend LaboratoriesApr 27, 2026 - Use cautionDrug
Ascend Laboratories, LLC recalls Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05),
Ascend Laboratories recalls specific lots of Atorvastatin Calcium Tablets USP, 80 mg due to failed dissolution specifications. Check your lot numbers.
Ascend LaboratoriesSep 19, 2025 - UnratedDrug
Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA;
Ascend Laboratories recalls 10mg Aripiprazole tablets (NDC 67877-432-03) due to superpotent drug hazard. Rx-only product manufactured in India, distributed in the US. Check your prescription label for recall details.
Ascend LaboratoriesAug 28, 2025 - UnratedDrug
Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories
Ascend Laboratories recalls specific lots of Amlodipine and Olmesartan Medoxomil tablets due to failed dissolution specifications. Check your bottle's lot number.
Ascend LaboratoriesJul 21, 2025 - UnratedDrug
Ascend Laboratories, LLC recalls Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories
Ascend Laboratories recalls 10mg Rizatriptan Benzoate Tablets with N-nitroso-dimethyl-rizatriptan impurity above FDA limits. Affected lots from India manufacturing, distributed in US. No remedy stated in recall notice.
Ascend LaboratoriesJul 9, 2025 - UnratedDrug
Ascend Laboratories, LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories
Ascend Laboratories recalls Cephalexin oral suspension due to impurity detected in stability testing. Affected lots expire by 2025-2026. No remedy specified in official notice.
Ascend LaboratoriesMay 23, 2025 - UnratedDrug
Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA,
Ascend Laboratories recalls 150mg Dabigatran Etexilate capsules (NDC 67877-475-60) due to presence of N-nitroso-Dabigatran impurity above safety limits. Rx only, manufactured in India, distributed in US.
Ascend LaboratoriesDec 12, 2024 - Lower riskDrug
Ascend Laboratories, LLC recalls Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem
Ascend Laboratories recalls 360 mg Mycophenolic Acid Delayed-Release Tablets due to failed dissolution specifications. This may affect medication effectiveness. Check NDC 67877-427-12 and lot numbers for affected batches.
Ascend LaboratoriesSep 3, 2024 - UnratedDrug
Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,
Ascend Laboratories recalls specific batches of fosfomycin granules for oral solution due to failed impurities testing. This may affect prescription medication safety.
Ascend LaboratoriesJan 16, 2024 - UnratedDrug
Ascend Laboratories, LLC recalls Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories
Ascend Laboratories recalls 90-tablet Ibuprofen and Famotidine tablets (Rx only) due to a stray Rasagiline Mesylate tablet found in unopened bottles. No remedy provided in official notice.
Ascend LaboratoriesDec 29, 2023 - Lower riskDrug
Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem
Ascend Laboratories recalls Fosfomycin Tromethamine Granules for Oral Solution due to impurities detected after 6 months of storage. Affected lots from June 2024 to September 2024. No remedy specified.
Ascend LaboratoriesJul 18, 2023 - Lower riskDrug
Ascend Laboratories, LLC recalls Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by:
Ascend Laboratories recalls 0.5mg Fingolimod capsules (NDC 67877-476-30) due to failed dissolution specifications. This may affect drug effectiveness.
Ascend LaboratoriesJul 11, 2023 - UnratedDrug
Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA
Ascend Laboratories recalls 20mg Aripiprazole tablets (NDC 67877-434-05) manufactured by Alkem Labs in India. The tablets failed a spectroscopic identification test, potentially affecting drug quality.
Ascend LaboratoriesMar 17, 2023 - UnratedDrug
Ascend Laboratories, LLC recalls Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd.,
Ascend Laboratories recalls 150mg Dabigatran Etexilate capsules (NDC 67877-475-60) due to detected N-nitroso-dabigatran impurities exceeding safety limits. Affected lots expire May 2024 or July 2024.
Ascend LaboratoriesMar 14, 2023 - Lower riskDrug
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem
Ascend Laboratories recalls 25mg Metoprolol Succinate Extended-Release Tablets due to failed dissolution specification. This may affect medication effectiveness. Check NDC 67877-590-01 and lot numbers 21143094-21143121.
Ascend LaboratoriesJan 5, 2023 - Lower riskDrug
Ascend Laboratories, LLC recalls Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem
Ascend Laboratories recalls Rasagiline Mesylate 1mg tablets due to black spots or shiny metallic specks. This Rx-only medication was manufactured by Alkem in India and distributed in the US. Consumers should check their bottles for these spots and contact the company for details.
Ascend LaboratoriesDec 28, 2022 - Use cautionDrug
Ascend Laboratories, LLC recalls Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem
Ascend Laboratories recalls 9,216 bottles of Metoprolol Succinate Extended-Release Tablets (25 mg) due to failed dissolution specifications.
Ascend LaboratoriesJan 12, 2022 - Use cautionDrug
Ascend Laboratories, LLC recalls Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India,
Ascend Laboratories recalls specific lots of Cefixime Capsules, 400 mg, due to failed impurity specifications. Check your bottle's lot number and expiration date.
Ascend LaboratoriesDec 21, 2021 - Use cautionDrug
Ascend Laboratories LLC recalls Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013,
Ascend Laboratories LLC recalls specific lots of Cefixime Capsules 400 mg due to failed impurity specifications. Check your bottle's lot number.
Ascend LaboratoriesNov 3, 2021 - UnratedDrug
Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013.
Ascend Laboratories recalls 20 mg Olmesartan Medoxomil tablets (NDC 67877-446-30) manufactured in India with foreign tablet risk. Stop using if you have the product.
Ascend LaboratoriesApr 29, 2021 - UnratedDrug
Ascend Laboratories LLC recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories,
Ascend Laboratories recalls Cephalexin oral suspension (250mg/5mL) with unidentified impurities above safety limits. This prescription medication was manufactured in India and distributed in the US. Consumers should not use the recalled product.
Ascend LaboratoriesJan 22, 2021 - UnratedDrug
Ascend Laboratories LLC recalls Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured
Ascend Laboratories recalls 250mg/5mL cephalexin oral suspension (NDC 67877-545-68) due to failed impurity specifications. Rx-only product manufactured in India, distributed in US. No remedy stated in official notice.
Ascend LaboratoriesDec 17, 2020 - Use cautionDrug
Ascend Laboratories LLC recalls Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013,
Ascend Laboratories recalls 1,200 bottles of Tizanidine 4mg tablets due to failed dissolution specifications. Check your lot number and expiration date.
Ascend LaboratoriesNov 24, 2020 - UnratedDrug
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)
Ascend Laboratories recalls Cephalexin oral suspension (125mg/5mL) due to unidentified impurities in some lots. Products may not meet safety standards.
Ascend LaboratoriesNov 23, 2020 - Lower riskDrug
Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai -
Ascend Laboratories recalls 20mg Olmesartan Medoxomil tablets due to manufacturing errors. This medication was released with an alternate active ingredient before approval. Consumers should contact the company for details.
Ascend LaboratoriesJan 24, 2020 - Lower riskDrug
Ascend Laboratories LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem
Ascend Laboratories recalls 105mg Minocycline Hydrochloride Extended-Release Tablets due to failed dissolution testing. This may affect medication effectiveness. Contact for return instructions.
Ascend LaboratoriesJan 22, 2020 - Use cautionDrug
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
Ascend Laboratories recalls specific lots of Atorvastatin Calcium Tablet USP 80 mg due to failed dissolution specifications. Check your bottle's NDC and lot number.
Ascend LaboratoriesJul 19, 2019 - Lower riskDrug
Ascend Laboratories LLC recalls Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd.,
Ascend Laboratories recalls 0.4 mg Tamsulosin capsules (NDC 67877-450-05) manufactured by Alkem Labs in India. The capsules failed dissolution tests during stability testing.
Ascend LaboratoriesFeb 22, 2019 - Use cautionDrug
Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,
Ascend Laboratories recalls 400mg Quetiapine tablets with metal shard risk. Stop using if you have these specific bottles. Details include NDC 67877-248-01 and lot 7143908.
Ascend LaboratoriesNov 14, 2018 - Lower riskDrug
Ascend Laboratories LLC recalls AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai -
Ascend Laboratories recalls 10mg Amlodipine Besylate tablets (NDC 67877-199-10) with foreign 2.5mg tablets. This may cause incorrect dosing if taken without knowing the tablet size.
Ascend LaboratoriesMay 5, 2017 - Lower riskDrug
Ascend Laboratories LLC recalls Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai -
Ascend Laboratories recalls 500mg Metformin tablets due to reports of Amlodipine tablets contaminating the product. This is a prescription-only medication.
Ascend LaboratoriesNov 2, 2016
Ascend Laboratories, LLC recall questions
How many recalls has Ascend Laboratories, LLC had?
50 recalls from Ascend Laboratories, LLC are on record with U.S. safety agencies, from 2016–2026.
What is the most recent Ascend Laboratories, LLC recall?
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured, dated Jul 16, 2026. Every Ascend Laboratories, LLC recall is listed on this page, newest first.
Why are Ascend Laboratories, LLC products recalled?
The most common reasons on record: Failed Dissolution Specifications (8); Failed Dissolution Specification (3); Failed Impurity/Degradation Specifications (2).
What should I do if I have a recalled Ascend Laboratories, LLC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Ascend Laboratories, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.