CLASS III Drug recall · Reported 26 Dec 2012 · FDA Enforcement Report
Caziant (desogestrel and ethinyl estradiol) Tablets recalled
Watson Laboratories is recalling Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1, distributed nationwide in the US. The recall was initiated on 13 Dec 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-094-2013
- FDA event ID
- 63906
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Dec 2012
- FDA classified
- 18 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 13 Dec 2012 | Recall initiated by company | |
| 18 Dec 2012 | Classified by FDA | +5 days |
| 26 Dec 2012 | Published in enforcement report | +8 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: Out-of-specification results were obtained for a known impurities.
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
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Which lots are affected?
432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13
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 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.
More recalls from Watson Laboratories
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories | Watson Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Next Choice" One Dose Emergency Contraceptive recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
Other Caziant (desogestrel recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Caziant (desogestrel and ethinyl estradiol) Tablets recalled | Watson Laboratories | Potency & Assay | Nationwide |