FDA Drug recall D-0152-2026
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02…
- FDA Drug
- Class II
- ongoing
- Published 2025-11-12
On 2025-11-12 the FDA classified a Class II recall of clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02… by Zydus Pharmaceuticals Usa, citing cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0152-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-22 |
| Published | 2025-11-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Reason
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Identifiers
| ndc | 16714-849-02 |
|---|---|
| ndc | 16714-849-01 |
| ndc | 16714-849-03 |
| ndc | 16714-850-01 |
| ndc | 16714-850-03 |
| ndc | 16714-850-02 |
| ndc | 16714-851-01 |
| ndc | 16714-851-03 |
| ndc | 16714-851-02 |
| code_info | a) Lot # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E40887…a) Lot # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026; Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026; Lot # E405281, Exp Date: 06/2026; Lot # E400387, Exp Date: 12/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0152-2026%22
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