Multi event Drug Recall Enforcement Report Class II voluntary initiated by Zydus Pharmaceuticals (USA) Inc, originally initiated on 10-22-2025 for the product clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India The product was recalled due to cgmp deviations: an observed out of specification of nitrosamine drug substance-related impurities (ndsris), n-nitroso desmethyl-clomipramine, above the fda acceptable intake limit.. The product was distributed in Distributed In One (1) State: Tx. and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0152-2026 | 10-22-2025 | 11-12-2025 | Class II | N/A | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Ongoing |
| D-0153-2026 | 10-22-2025 | 11-12-2025 | Class II | N/A | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Ongoing |
| D-0154-2026 | 10-22-2025 | 11-12-2025 | Class II | N/A | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 16714-849 | Clomipramine Hydrochloride | Clomipramine Hydrochloride | Capsule | Oral | Northstar Rx Llc. | Human Prescription Drug |
| 16714-850 | Clomipramine Hydrochloride | Clomipramine Hydrochloride | Capsule | Oral | Northstar Rx Llc. | Human Prescription Drug |
| 16714-851 | Clomipramine Hydrochloride | Clomipramine Hydrochloride | Capsule | Oral | Northstar Rx Llc. | Human Prescription Drug |
