Zydus Pharmaceuticals (USA) Inc
Zydus Pharmaceuticals (USA) Inc appears in FDA public data with 54 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0745-2026, Class II) was initiated on August 5, 2026.
Summary
- Total Recalls
- 54 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Known Names
zydus pharmaceuticals (usa), zydus pharmaceuticals usa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0745-2026 | Class II | Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesci | August 5, 2026 |
| D-0545-2026 | Class II | Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifescienc | April 29, 2026 |
| D-0544-2026 | Class II | Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifescienc | April 29, 2026 |
| D-0400-2026 | Class II | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthc | March 9, 2026 |
| D-0295-2026 | Class II | Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pv | December 30, 2025 |
| D-0247-2026 | Class III | traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifescie | December 19, 2025 |
| D-0159-2026 | Class II | Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus | October 23, 2025 |
| D-0154-2026 | Class II | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01) | October 22, 2025 |
| D-0152-2026 | Class II | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01) | October 22, 2025 |
| D-0153-2026 | Class II | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01) | October 22, 2025 |
| D-0001-2026 | Class II | Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., | September 24, 2025 |
| D-0002-2026 | Class II | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah | September 24, 2025 |
| D-0657-2025 | Class II | Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedab | September 4, 2025 |
| D-0656-2025 | Class II | Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmed | September 4, 2025 |
| D-0638-2025 | Class II | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus | September 3, 2025 |
| D-0633-2025 | Class II | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus | September 3, 2025 |
| D-0630-2025 | Class II | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus | September 3, 2025 |
| D-0634-2025 | Class II | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus | September 3, 2025 |
| D-0632-2025 | Class II | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus | September 3, 2025 |
| D-0636-2025 | Class II | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus | September 3, 2025 |