CLASS II Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Rasagiline Mesylate Tablets 1 mg; in HDPE recalled
Ascend Laboratories is recalling Rasagiline Mesylate Tablets 1 mg; in HDPE, distributed in 20 states. The recall was initiated on 28 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0159-2023
- FDA event ID
- 91385
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Brand
- Rasagiline
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Dec 2022
- FDA classified
- 16 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 28 Dec 2022 | Recall initiated by company | |
| 16 Jan 2023 | Classified by FDA | +19 days |
| 25 Jan 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Product as listed by the FDA
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 was distributed
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
CaliforniaFloridaGeorgiaIllinoisKentuckyLouisianaMichiganMinnesotaMississippiNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaPuerto RicoRhode IslandTennesseeTexasWashingtonWisconsin
Questions about this recall
Why was it recalled?
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Which lots are affected?
Lot # 22140903. Exp. Dec. 2024
Where was it sold?
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
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ascend Laboratories
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dabigatran Etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran etexilate Capsules, 110 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
Other Rasagiline recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rasagiline Tablets 0.5mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Rasagiline Mesylate, Tablet, 0.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |