CLASS III Drug recall · Reported 8 Sep 2021 · FDA Enforcement Report
Donepezil HCL Tablets, USP, 5 mg recalled by Jubilant Cadista
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 20 Aug 2021 and the FDA has classified it as Class III.
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-0784-2021
- FDA event ID
- 88523
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Aug 2021
- FDA classified
- 31 Aug 2021
- Reported
- 8 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 Aug 2021 | Recall initiated by company | |
| 31 Aug 2021 | Classified by FDA | +11 days |
| 8 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent
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
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Why was it recalled?
Subpotent
Which lots are affected?
Lot # DN120006A, exp. date 12/2021
Where was it sold?
Product was distributed 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Donepezil recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Donepezil HCl Tablets, 10 mg recalled by Cardinal HealthcareDonepezil Hydrochloride | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Donepezil HCl Tablets, 5 mg recalled by Cardinal HealthcareDonepezil Hydrochloride | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Donepezil HCl tablets, 10mg recalled by Mckesson Packaging Services | Mckesson Packaging Services | Potency & Assay | CO, LA, OH |
| Drug | CLASS III | Donepezil Hydrochloride Tablets, 10 mg recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |