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
August 12, 2026FDAMirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zy…D-0745-2026
May 27, 2026FDAErythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus…D-0544-2026
May 27, 2026FDAErythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus…D-0545-2026
March 18, 2026FDAIcosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Soft…D-0400-2026
January 28, 2026FDAIcosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel He…D-0295-2026
January 7, 2026FDAtraZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zyd…D-0247-2026
November 26, 2025FDABromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured…D-0159-2026
November 12, 2025FDAclomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16…D-0152-2026
November 12, 2025FDAclomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16…D-0153-2026
November 12, 2025FDAclomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16…D-0154-2026
October 8, 2025FDAEntecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifescie…D-0001-2026
October 8, 2025FDAEntecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifescienc…D-0002-2026
September 24, 2025FDAEntecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences …D-0656-2025
September 24, 2025FDAEntecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Lt…D-0657-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufacture…D-0637-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured…D-0635-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufacture…D-0638-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured…D-0633-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufacture…D-0632-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufacture…D-0636-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured…D-0631-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured…D-0634-2025
September 17, 2025FDASuccinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-…D-0623-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured…D-0630-2025
September 17, 2025FDAChlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufacture…D-0639-2025

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.
What was the most recent Zydus Pharmaceuticals (USA) Inc recall?
FDA recall D-0745-2026, published August 12, 2026: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,…
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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