Zydus Pharmaceuticals (USA) Inc: 85 recalls on record

Recalls filed with 1 agency: FDA (85).

First recall on record: August 8, 2012. Most recent: August 12, 2026.

Risk classification: Class I: 2 · Class II: 69 · Class III: 14

Most recent recalls

DateAgencyProduct
June 18, 2025FDAIcosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel…D-0497-2025
May 28, 2025FDAEsomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose P…D-0442-2025
May 28, 2025FDAEsomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose p…D-0443-2025
April 16, 2025FDAVenlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, A…D-0310-2025
April 16, 2025FDAchlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactur…D-0361-2025
March 12, 2025FDANelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 7…D-0256-2025
March 12, 2025FDANelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 7…D-0255-2025
December 11, 2024FDAEsomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets,…D-0102-2025
July 31, 2024FDAVenlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count …D-0617-2024
July 24, 2024FDACyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufacture…D-0600-2024
July 17, 2024FDAMicafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Z…D-0595-2024
July 17, 2024FDAVerapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial …D-0593-2024
July 17, 2024FDAMicafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: …D-0596-2024
July 17, 2024FDAVerapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Sin…D-0592-2024
June 12, 2024FDAEstradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: …D-0542-2024
June 12, 2024FDAEstradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: C…D-0543-2024
November 15, 2023FDAOxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manuf…D-0097-2024
November 15, 2023FDAOxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufa…D-0096-2024
November 15, 2023FDAOxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manuf…D-0098-2024
October 11, 2023FDAOxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01)…D-0038-2024
March 22, 2023FDAColchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) …D-0467-2023
August 24, 2022FDAFulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx…D-1351-2022
August 25, 2021FDACarvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Heal…D-0753-2021
April 7, 2021FDAAcyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous I…D-0315-2021
December 23, 2020FDALansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit…D-0145-2021

Questions about this company

How many recalls does Zydus Pharmaceuticals (USA) Inc have?
Recalert has 85 U.S. recalls on record for Zydus Pharmaceuticals (USA) Inc, published between August 8, 2012 and August 12, 2026.
Which agencies have handled Zydus Pharmaceuticals (USA) Inc recalls?
Zydus Pharmaceuticals (USA) Inc appears as the recalling firm in recalls from: FDA (85).

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