Paliperidone Extended-Release Tablets Recalled for Failed Dissolution
The Harvard Drug Group is recalling 174 cartons of Paliperidone Extended-Release Tablets, 9 mg, nationwide due to failed dissolution specifications. The affected lots are N00522 (Exp. 09/2022) and N00618 (Exp. 11/2022).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall. The source text indicates no reported illnesses or injuries, and the hazard is a manufacturing defect (failed dissolution) that affects drug delivery rather than safety contamination. Class II recalls with no reported harm and precautionary or corrective action without immediate health danger typically score 2 (Moderate).
Plain-English summary
The Harvard Drug Group is recalling Paliperidone Extended-Release Tablets, 9 mg (100 tablets per carton), distributed nationwide in the United States. The recall involves 174 cartons across two lots: Lot #N00522 with expiration date 09/2022 and Lot #N00618 with expiration date 11/2022. The product is identified by NDC 0904-6937-61 and was manufactured by Sun Pharmaceutical Industries Ltd. in Dadra, India, and distributed by Major Pharmaceuticals in Livonia, Michigan.
The recall is due to failed dissolution specifications. This means the tablets do not dissolve at the appropriate rate in the body, potentially affecting drug delivery and therapeutic effectiveness.
Consumers who have received this medication should contact their healthcare provider or pharmacist before discontinuing use. Healthcare providers should verify patient medication inventory and consult the FDA and manufacturer guidance regarding patient management and product replacement.
The recalled product
- Product
- PALIPERIDONE (PALIPERIDONE)
- Brand
- PALIPERIDONE
- Manufacturer
- The Harvard Drug Group
- Affected units
- 174
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 (4)
- Lot #: N00522
- Exp. Date 09/2022
- N00618
- Exp. Date 11/2022
Distribution
Distributed nationwide across the United States.
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