CLASS II Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report
Amantadine Hydrochloride Tablets, 100 mg recalled by Jubilant Cadista
Jubilant Cadista Pharmaceuticals is recalling Amantadine Hydrochloride Tablets, 100 mg, distributed nationwide in the US. The recall was initiated on 2 Dec 2019 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-0576-2020
- FDA event ID
- 84396
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 6 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 6 Dec 2019 | Classified by FDA | +4 days |
| 18 Dec 2019 | Published in enforcement report | +12 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: Presence of a foreign object in a single tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Presence of a foreign object in a single tablet.
Which lots are affected?
Lot #: NT119005A, Exp 07/2021
Where was it sold?
Nationwide in the USA.
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 Jubilant Cadista Pharmaceuticals
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride | Jubilant Cadista Pharmaceuticals | Labeling Errors | 5 states |
Other Amantadine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Amantadine Hydrochloride Oral Solution USP, 50mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Amantadine Hydrochloride Tablets 100 mg recalled by Cardinal HealthAmantadine Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Amantadine HCl Capsules, USP, 100 mg Unite Dose recalled by AVKAREAmantadine Hcl | Avkare | Potency & Assay | Nationwide |
| Drug | CLASS II | Amantadine HCl Capsules, USP, 100 mg recalled by Apace KY | Apace KY | Other | KY |