UnratedDrug recall · FDA · Published March 17, 2023
Ascend Laboratories recalls 20mg Aripiprazole tablets due to spectroscopic test failure
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 Laboratories recalls 20mg Aripiprazole tablets due to spectroscopic test failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33794-ascend-laboratories-recalls-20mg-aripiprazole-tablets-due-to-spectroscopic-test. Based on FDA recall #D-0539-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0539-2023%22&limit=1).
The FDA announced on March 17, 2023, that Ascend Laboratories, LLC is recalling Aripiprazole Tablets, USP, 20 mg due to out-of-specification spectroscopic identification results. The agency issued recall number D-0539-2023 for the Class II voluntary recall.
The recall is due to out-of-specification results for the Spectroscopic Identification test by IR. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Ascend Laboratories, LLC has 35 other recalls on record since November 2, 2016. Other recent recalls of similar products include Apotex Paxil CR 37.5mg Tablets Recall (August 13, 2026), Viatris Xanax XR 3mg Tablets Recall (March 17, 2026), and Meclizine 12.5mg Tablets Recall (March 16, 2026).
How to tell if you have this one
Check for the 20mg Aripiprazole tablets in 500-count bottles with NDC number 67877-434-05. The lot number is 22143120, and the expiration date is June 2024.
Brand
Ascend Laboratories
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC number 67877-434-05 on the bottle label to confirm the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0539-2023 (March 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0539-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.