Recall archive / FDA company announcement

Lupin Pharmaceuticals, Inc.: Tydemy oral contraceptive — FDA announcement Jul 31, 2023

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jul 31, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Tydemy oral contraceptive
Reason: Out of Specification Results
Classification: Not supplied
Recalling firm: Lupin Pharmaceuticals, Inc.
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: 0d8ce56903de9c90

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Baltimore, Maryland, July 28, 2023: Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.; Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28’s blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton.; Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.; Product \| Lot No \| Expiry \| NDC(s) \| UPC \| Distribution Dates; TydemyTM \| L200183 \| Jan. 2024 \| 68180-904-71 (1 Blister of 28 tablets each) 68180-904-73 (3 Blister of 28 tablets each) \| 368180904731 \| June 2022 to May 2023; L201560 \| Sep. 2024

Label field

Details supplied by the agency

Lot, code or applicability

Baltimore, Maryland, July 28, 2023: Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.; Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28’s blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton.; Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.; Product | Lot No | Expiry | NDC(s) | UPC | Distribution Dates; TydemyTM | L200183 | Jan. 2024 | 68180-904-71 (1 Blister of 28 tablets each) 68180-904-73 (3 Blister of 28 tablets each) | 368180904731 | June 2022 to May 2023; L201560 | Sep. 2024

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product	Lot No	Expiry	NDC(s)	UPC	Distribution Dates
TydemyTM	L200183	Jan. 2024	68180-904-71 (1 Blister of 28 tablets each) 68180-904-73 (3 Blister of 28 tablets each)	368180904731	June 2022 to May 2023
TydemyTM	L201560	Sep. 2024		368180904731	June 2022 to May 2023

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Jul 31, 2023
Company announcement date: Jul 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.