Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg a...
FDA Drug Recall #D-1081-2023 — Class I — June 23, 2023
Recall Summary
| Recall Number | D-1081-2023 |
| Classification | Class I — Serious risk |
| Date Initiated | June 23, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lupin Pharmaceuticals Inc. |
| Location | Baltimore, MD |
| Product Type | Drugs |
| Quantity | 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch |
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
Reason for Recall
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Distribution Pattern
USA nationwide.
Lot / Code Information
Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024
Other Recalls from Lupin Pharmaceuticals Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0541-2026 | Class II | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx... | Apr 24, 2026 |
| D-0220-2026 | Class II | Ganirelix Acetate Injection, 250 mcg/0.5mL, Sin... | Nov 13, 2025 |
| D-0227-2026 | Class II | Sertraline Hydrochloride Tablets USP, 100 mg, 9... | Nov 5, 2025 |
| D-0542-2025 | Class II | Amlodipine and Benazepril HCl Capsules USP 2.5 ... | Jul 2, 2025 |
| D-0537-2025 | Class II | clomiPRAMINE Hydrochloride Capsules USP 25 mg, ... | Jun 27, 2025 |
Frequently Asked Questions
Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.