CLASS III Drug recall · Reported 8 Aug 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 5 Jun 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-1436-2012
- FDA event ID
- 62407
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jun 2012
- FDA classified
- 1 Aug 2012
- Reported
- 8 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 5 Jun 2012 | Recall initiated by company | |
| 1 Aug 2012 | Classified by FDA | +57 days |
| 8 Aug 2012 | 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: High Out-of-specification results were obtained for both known and unknown 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: High Out-of-specification results were obtained for both known and unknown impurities.
Which lots are affected?
Lot #s: 412572A, 412572B, Exp 11/12
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 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
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|---|---|---|---|---|---|
| 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 |