Teva Recalls Niacin Extended Release Tablets Due to Broken Tablets
Teva Pharmaceuticals is recalling Niacin Extended Release Tablets, 500 mg, because the tablets may be broken.
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: The recall is classified as FDA Class II, and the hazard involves a physical defect (broken tablets) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Teva Pharmaceuticals USA is recalling Niacin Extended Release Tablets, USP, 500 mg, 90 count bottles. The recall is due to a potential for broken tablets.
The affected product is identified by NDC 0093-7392-98, Lot number 32900349B, and an expiration date of 12/2014. A total of 10,512 bottles were distributed nationwide and to Puerto Rico, American Samoa, the Virgin Islands, and the Canal Zone.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,512
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 (2)
- Lot#: 32900349B
- Exp: 12/2014
Distribution
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