ZARAH Tablets (Watson) – Tablet Breakage (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28
Brand
Watson Laboratories Inc
Lot Codes / Batch Numbers
Lot #s: 401536AA/401536A, 401537AA/401537/A, 401538AA/401538/A, 406985AA/406985A, 432058AA/432058A, 512685AA/512685A
Products Sold
Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
Watson Laboratories Inc is recalling ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tab due to Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026