FDA drug recalls · openFDA
Is CHLORPROMAZINE HYDROCHLORIDE recalled?
The FDA has recorded 30 recalls of CHLORPROMAZINE HYDROCHLORIDE (2024–2025) , recalled under brand like CHLORPROMAZINE HYDROCHLORIDE. 30 still ongoing.
0
Class I (most serious)
30
Class II
0
Class III
30
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of CHLORPROMAZINE HYDROCHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit 10
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit 5
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturi 4
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected wit 4
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommende 2
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z306327, Exp Date 30-11-25; Z306748, Exp Date 30-11-25; Z401154, Exp Date 28-02-26; Z403738, Exp Date 31-05-26; Z405645, Exp Date 30-09-26
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Class II ongoing
Amerisource Health Services LLC 2025-08-27 lots: Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z403012, Exp Date 30-04-26; Z406657, Exp Date 30-11-26
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z305456, Exp Date 31-10-25; Z401156, Exp Date 28-02-26; Z407306, Exp Date 30-11-26
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-04-03 lots: Lot #: Z400069, Exp.: 12/31/2025
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z305062, exp 31-08-25; Z306324, Exp Date 30-11-25; Z401151, Z401152, Exp Date 28-02-26
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z305060, Z305061, Exp Date 31-08-25; Z306323, Exp Date 30-11-25; Z401153, Exp Date 28-02-26; Z403015, Z403016, Exp Date 30-04-26; Z405591, Exp Date 30-09-26
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare Class II ongoing
AvKARE 2025-08-25 lots: Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Pac Class II ongoing
Amerisource Health Services LLC 2025-08-27 lots: Lot: 1022159, exp 12/31/2026; 1023299, exp 03/31/2027; 1024057, Exp 04/30/2027
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Dist Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-09-12 lots: Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pv Class II ongoing
Amneal Pharmaceuticals, LLC 2025-08-18 lots: Lot: AM240336, AM240337, Exp Date 02/28/2027.
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals P Class II ongoing
Amneal Pharmaceuticals, LLC 2025-08-18 lots: Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z305085, Exp Date 30-09-25; Z401166, Z401167, Exp Date 28-02-26
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pv Class II ongoing
Amneal Pharmaceuticals, LLC 2025-08-18 lots: Lot AM240617, AM240618, Exp Date 04/30/2027
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Dist Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-09-12 lots: Lots N02009 & N02026, exp. date 02/28/2026
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distr Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-09-12 lots: Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z306326, Exp Date 30-11-25; Z401155, Exp Date 28-02-26
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKar Class II ongoing
AvKARE 2025-08-25 lots: Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Class II ongoing
Amerisource Health Services LLC 2025-08-27 lots: Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distrib Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-09-12 lots: Lots N01943 and Lot N02025, exp. date 02/28/2026
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt Class II ongoing
Amneal Pharmaceuticals, LLC 2025-08-18 lots: Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Dist Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-09-12 lots: Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Class II ongoing
Amerisource Health Services LLC 2025-08-27 lots: Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Dist Class II ongoing
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-04-14 lots: Lot#: N02114, Exp 12/31/2025
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceut Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-03-11 lots: Lot#s: 17232222 and 17232237, Exp 10/31/2025
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B Class II ongoing
Zydus Pharmaceuticals (USA) Inc 2025-09-03 lots: Lot#: Z403011, Exp Date 30-04-26; Z407335, Exp Date 30-11-26
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals I Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-12-11 lots: Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-12-11 lots: Lot#: 17230133, Exp 12/31/2024
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.