Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Cipla Limited

NDC code

69097-403-02

Origin

India

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0382-2019

Other Pine recalls

See all

Class II · Moderate risk Ongoing Jul 8, 2026

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories…

Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Ascend Laboratories, LLC D-0712-2026

Class II · Moderate risk Ongoing Jul 6, 2026

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA…

Reason Lack of Assurance of Sterility

Chiesi USA, Inc. NDC 10122-611-10 D-0689-2026

Class III · Low risk Ongoing May 14, 2026

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02…

Reason Failed Impurities/Degradations Specifications

Fresenius Kabi USA, LLC NDC 63323-696-02 D-0581-2026

Class II · Moderate risk Ongoing May 5, 2026

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India…

Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Ascend Laboratories, LLC NDC 67877-501-30 D-0556-2026

Class II · Moderate risk Ongoing Apr 1, 2026

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An…

Reason Lack of Assurance of Sterility

International Medication Systems Ltd. NDC 76329-3318-1 D-0483-2026