CLASS II Drug recall · Reported 16 Jul 2014 · FDA Enforcement Report
Fluvastatin Capsules USP, 20 mg recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals U is recalling Fluvastatin Capsules USP, 20 mg, distributed nationwide in the US. The recall was initiated on 29 May 2014 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-1430-2014
- FDA event ID
- 68441
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Brand
- Fluvastatin
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2014
- FDA classified
- 10 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 29 May 2014 | Recall initiated by company | |
| 10 Jul 2014 | Classified by FDA | +42 days |
| 16 Jul 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: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Product as listed by the FDA
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56
Where it was distributed
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Questions about this recall
Is Fluvastatin Capsules USP, 20 mg recalled?
Yes. Teva Pharmaceuticals U recalled Fluvastatin Capsules USP, 20 mg on 29 May 2014. The recall is Class II and its status is Terminated. Recall number D-1430-2014.
Why was it recalled?
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Which lots are affected?
Lot #: F47008, Exp. 7/2015
Where was it sold?
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
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 21 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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