Sandoz Recalls Subpotent Donepezil Hydrochloride Tablets
Sandoz Inc. is recalling specific lots of Donepezil Hydrochloride 10 mg tablets because they failed potency tests. The medication may not contain the full prescribed dose.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation unlikely to cause adverse health consequences. The hazard is subpotency, which is a quality issue rather than a direct physical injury risk like choking or fire.
Plain-English summary
Sandoz Inc. is recalling Donepezil Hydrochloride Tablets, 10 mg, in 30-count and 1,000-count bottles. The recall affects specific lots manufactured in India by Sandoz Private Ltd for Sandoz Inc. The affected products are prescription-only medications distributed nationwide in the United States.
The recall was initiated because the tablets failed to meet specification results for the assay test, indicating they are subpotent. This means the medication may not contain the full amount of the active ingredient required by the label.
Patients and healthcare providers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, it should be returned to the pharmacy or contact Sandoz for a replacement or refund. Consumers should not discontinue their medication without consulting their healthcare provider.
The recalled product
- Product
- Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) FJ6599
- Exp 05/17 and b) FJ6600
- Exp 05/17
Distribution
Distributed nationwide across the United States.
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