Prescription Birth Control Tablets Recalled for Failed Stability Testing
Lupin Pharmaceuticals is recalling TYDEMY birth control tablets due to failed stability testing. Consumers should contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall with no reported illnesses or injuries. Specification failures in a prescription drug warrant Severe (4) severity, the minimum threshold for Class I classifications.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling TYDEMY, a prescription oral contraceptive containing drospirenone, ethinyl estradiol, and levomefolate calcium. The product is distributed in 28-tablet blister packs.
The recall was initiated because the product failed stability testing and failed impurities and degradation testing. The FDA found that the inactive ingredient ascorbic acid and the impurity MTHFRC-7 were out of specification.
The affected lot numbers are L200183 (expiring January 2024) and L201560 (expiring September 2024). These lots were distributed nationwide; approximately 4,179 cartons were affected.
Consumers currently taking this product should contact their healthcare provider or pharmacist immediately to discuss whether they should switch to an alternative contraceptive.
The recalled product
- Product
- TYDEMY (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM)
- Brand
- TYDEMY
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptive
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 (4)
- Lot #: L200183
- Exp 1/2024
- L201560
- Exp 9/2024
UPCs (1)
- 0368180904717
Distribution
Distributed nationwide across the United States.
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