Watson Recalls Zarah Oral Contraceptive Tablets Due to Breakage
Watson Laboratories is recalling Zarah oral contraceptive tablets because they may break while being pushed through the blister pack.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves tablet breakage during dispensing, which is a quality defect without reported injuries or serious health consequences.
Plain-English summary
Watson Laboratories, Inc. is recalling Zarah (Drospirenone/Ethinyl Estradiol) Tablets, 3.0 mg/0.03 mg, prescription only. The recall involves 136,720 cartons of the medication, which were distributed nationwide.
The recall was initiated because the tablets failed to meet specifications, specifically breaking while being pushed through the blister pack dispenser. The affected lots are 401536AA/401536A, 401537AA/401537/A, 401538AA/401538/A, 406985AA/406985A, 432058AA/432058A, and 512685AA/512685A.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- 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
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Oral Contraceptive
- Affected units
- 136,720
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #s: 401536AA/401536A
- 401537AA/401537/A
- 401538AA/401538/A
- 406985AA/406985A
- 432058AA/432058A
- 512685AA/512685A
Distribution
Distributed nationwide across the United States.
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