Class II · Moderate risk
Donepezil HCl Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Donepezil HCL Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
59746-0329-90
Compare with the code on your package — it is the most precise check available.
Drug: Donepezil
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- NDC code
- 59746-329-90
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0784-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Donepezil recalls
See all
Class II · Moderate risk
Donepezil HCl Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Namzaric (memantine HCl extended release and donepezil HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Donepezil HCl tablets
Supotent: Out of Specification result for assay test during routine stability testing.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
Other recalls by Jubilant Cadista Pharmaceuticals, Inc.
All 2021 recalls
Class III · Low risk
Prochlorperazine Maleate Tablets
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class II · Moderate risk
Irbesartan Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Irbesartan Tablets
Failed dissolution specifications.
Class III · Low risk
Methylprednisolone Tablets
Subpotent
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