Recall record at a glance
| Official record | D-1081-2023 |
|---|---|
| Category | Drug Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Report date | Aug 9, 2023 |
| Recall initiation date | Jun 23, 2023 |
| Quantity | 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch |
| Location | Baltimore, MD, United States |
Official product description
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA
Why the product was recalled
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Distribution information
USA nationwide.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.