CLASS II Drug recall · Reported 27 Sep 2023 · FDA Enforcement Report
Rasagiline Tablets 0.5mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Rasagiline Tablets 0.5mg, distributed nationwide in the US. The recall was initiated on 2 Aug 2023 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-1171-2023
- FDA event ID
- 92948
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Aug 2023
- FDA classified
- 18 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 2 Aug 2023 | Recall initiated by company | |
| 18 Sep 2023 | Classified by FDA | +47 days |
| 27 Sep 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
Failed dissolution specifications - results obtained were below spec average.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
Failed dissolution specifications - results obtained were below spec average.
Which lots are affected?
Lot #: 3112444, Exp 8/2023
Where was it sold?
USA nationwide
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 Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Rasagiline recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rasagiline Mesylate Tablets 1 mg; in HDPE recalledRasagiline | Ascend Laboratories | Other | 20 states |
| Drug | CLASS II | Rasagiline Mesylate, Tablet, 0.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |