Home / Recalls / Lupin Pharmaceuticals Inc. / D-1081-2023

D-1081-2023 Class I Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
August 9, 2023
Initiation Date
June 23, 2023
Termination Date
January 28, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

Code Information

Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024

Other recalls by Lupin Pharmaceuticals Inc.

  • D-0220-2026 Class II — Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syring (November 13, 2025)
  • D-0227-2026 Class II — Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manuf (November 5, 2025)
  • D-0542-2025 Class II — Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx (July 2, 2025)
  • D-0537-2025 Class II — clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican B (June 27, 2025)
  • D-0532-2025 Class II — Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, R (June 20, 2025)
  • D-0377-2025 Class II — clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manuf (April 10, 2025)
  • D-0167-2025 Class II — Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Ma (December 20, 2024)
  • D-0052-2025 Class II — Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 6 (October 23, 2024)
  • D-0053-2025 Class II — Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 681 (October 23, 2024)
  • D-0054-2025 Class II — Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68 (October 23, 2024)