Lower riskDrug recall · FDA · Published December 28, 2022
Ascend Rasagiline Tablets Recall: Black Spots on Tablets
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 Laboratories is recalling Rasagiline Mesylate 1 mg tablets because some have black spots or shiny metallic specks. This issue could affect the medication's safety and effectiveness, so affected users should stop using the tablets and contact the company. Read more at govinfonow.com/recall/34044-ascend-rasagiline-tablets-recall-black-spots-on-tablets.
“Ascend Rasagiline Tablets Recall: Black Spots on Tablets.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34044-ascend-rasagiline-tablets-recall-black-spots-on-tablets. Based on FDA recall #D-0159-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0159-2023%22&limit=1).
The FDA announced on Dec. 28, 2022, that Ascend Laboratories, LLC voluntarily recalled Rasagiline Mesylate Tablets 1 mg due to the presence of black spots and shiny metallic specks. The agency issued recall number D-0159-2023 for the Class II drug.
How to tell if you have it
Brand: Ascend Laboratories
Product: Rasagiline Mesylate Tablets 1 mg
Packaging: 30 tablets in HDPE bottle
NDC: 67877-260-30
Lot #: 22140903
Expiration: Dec. 2024
Quantity: 12,192 bottles
Sold in: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, RI, TN, TX, WA, WI, and Puerto Rico
The hazard
The recall addresses complaints of black spots or shiny metallic specks found on the tablets. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Ascend Laboratories, LLC has issued 35 other recalls since Nov. 2, 2016. Recent brand recalls include Dabigatran Etexilate Capsules recalled on July 16, 2026, due to impurity risks and Amlodipine/Olmesartan tablets recalled on July 8, 2026, for low drug content. Other recent recalls of similar products include Sun Pharmaceutical Carbamazepine Tablets Recall (Aug. 3, 2026) and Bionpharma Divalproex Tablets Recall (June 26, 2026).
How to tell if you have this one
Check for black spots or shiny metallic specks on the tablets. The product is a 1 mg Rasagiline Mesylate tablet in a HDPE bottle with NDC 67877-260-30, manufactured by Alkem in India and distributed by Ascend Laboratories.
Brand
Ascend Laboratories
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check for Spots
Look for black spots or shiny metallic specks on the tablets.
Where it went and when
Where it was distributed
Distributed in 19 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0159-2023 (December 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0159-2023 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.