FDA Drug recall D-0576-2020
Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India
- FDA Drug
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India by Jubilant Cadista Pharmaceuticals, citing presence of Foreign Substance: Presence of a foreign object in a single tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0576-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-02 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
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
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Identifiers
| code_info | Lot #: NT119005A, Exp 07/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0576-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.