CLASS III Drug recall · Reported 23 Jan 2013 · FDA Enforcement Report
Cabergoline Tablets, 5 mg recalled by Teva Pharmaceuticals USA
Teva Pharmaceuticals USA is recalling Cabergoline Tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 24 Apr 2012 and the FDA has classified it as Class III.
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-128-2013
- FDA event ID
- 61725
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Brand
- Cabergoline
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Apr 2012
- FDA classified
- 16 Jan 2013
- Reported
- 23 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Apr 2012 | Recall initiated by company | |
| 16 Jan 2013 | Classified by FDA | +267 days |
| 23 Jan 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Where it was distributed
Nationwide
Questions about this recall
Is Cabergoline Tablets, 5 mg recalled?
Yes. Teva Pharmaceuticals USA recalled Cabergoline Tablets, 5 mg on 24 Apr 2012. The recall is Class III and its status is Terminated. Recall number D-128-2013.
Why was it recalled?
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Which lots are affected?
Lot number 6A007046V, exp 07/12
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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|---|---|---|---|---|---|
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