Amantadine Hydrochloride Tablets — Class II drug recall D-0576-2020
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2019-12-18, distributed nationwide. Presence of Foreign Substance: Presence of a foreign object in a single tablet.
| Recall number | D-0576-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2019-12-02 |
| Classified | 2019-12-06 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2021-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,824 bottles |
| Reason classes | foreign material |
| NDC | 59746-0699-01 |
| Lot numbers | NT119005A |
| Expiration dates | 2021-07 |
Product
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.
Reason for recall
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0576-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.