Home / Recalls / Lupin Pharmaceuticals Inc. / D-0537-2025

D-0537-2025 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Naples, FL

Recall Details

Product Type
Drugs
Report Date
July 30, 2025
Initiation Date
June 27, 2025
Termination Date
January 5, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,724 bottles

Product Description

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

Reason for Recall

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

Distribution Pattern

Nationwide.

Code Information

Lot # M300464, exp. date June, 2025

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-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-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)
  • 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-0648-2024 Class II — Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactur (August 21, 2024)