CLASS II Drug recall · Reported 8 Jan 2014 · FDA Enforcement Report
Niacin Extended Release Tablets, USP, 500 mg recalled
Teva Pharmaceuticals USA is recalling Niacin Extended Release Tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 26 Nov 2013 and the FDA has classified it as Class II.
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-396-2014
- FDA event ID
- 66955
- Recalling firm
- Teva Pharmaceuticals USA, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2013
- FDA classified
- 2 Jan 2014
- Reported
- 8 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 26 Nov 2013 | Recall initiated by company | |
| 2 Jan 2014 | Classified by FDA | +37 days |
| 8 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Product as listed by the FDA
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
Where it was distributed
Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Which lots are affected?
Lot#: 32900349B, Exp: 12/2014
Where was it sold?
Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
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Other Niacin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP, 1,000 mg recalledNiacin | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP 1000mg recalledNiacin | SUN Pharmaceutical Industries | Sterility | Nationwide |