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Chlorpromazine Hydrochloride
Chlorpromazine Hydrochloride recalls: 24 FDA reports
Recalls involving Chlorpromazine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.
24Reports
0Class I
24Ongoing
2025-09-24Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by
D-0650-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
- Where it went
- Nationwide in the USA
- How much
- 873 cartons
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American
D-0648-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
- Where it went
- Nationwide in the USA
- How much
- 1,062 cartons
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by
D-0649-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
- Where it went
- Nationwide in the USA
- How much
- 1,757 cartons
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (I
D-0647-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
- Where it went
- Nationwide in the USA
- How much
- 2,708 cartons
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescienc
D-0634-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
- Where it went
- Nationwide in the USA
- How much
- N/A
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescienc
D-0630-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
- Where it went
- Nationwide in the USA
- How much
- N/A
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescien
D-0637-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
- Where it went
- Nationwide in the USA
- How much
- N/A
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescienc
D-0633-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
- Where it went
- Nationwide in the USA
- How much
- N/A
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescien
D-0632-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1
- Where it went
- Nationwide in the USA
- How much
- N/A
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured f
D-0643-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- Presence of a foreign substance.
- Product
- chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
- Where it went
- USA Nationwide
- How much
- 1512 cartons
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescien
D-0639-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
- Where it went
- Nationwide in the USA
- How much
- N/A
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescienc
D-0635-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
- Where it went
- Nationwide in the USA
- How much
- N/A
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured
D-0644-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- Presence of a foreign substance.
- Product
- chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
- Where it went
- USA Nationwide
- How much
- 2003 cartons
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescien
D-0636-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
- Where it went
- Nationwide in the USA
- How much
- N/A
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescien
D-0638-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
- Where it went
- Nationwide in the USA
- How much
- N/A
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifescienc
D-0631-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Product
- Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01
- Where it went
- Nationwide in the USA
- How much
- N/A
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmace
D-0619-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
- Where it went
- Distributed Nationwide in the USA
- How much
- 3,363 100-count bottles
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmac
D-0618-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
- Where it went
- Distributed Nationwide in the USA
- How much
- 14,923 100-count bottles
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmace
D-0616-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
- Where it went
- Distributed Nationwide in the USA
- How much
- 7,228 100-count bottles
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceu
D-0617-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
- Where it went
- Distributed Nationwide in the USA
- How much
- 13,130 100-count bottles
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifescie
D-0361-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
- Product
- chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1
- Where it went
- Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA
- How much
- 3144 bottles, pack size: 100's Count
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark
D-0309-2025 · Class II · reported 2025-04-09 · Ongoing
- Why it was recalled
- CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
- Where it went
- Nationwide in the USA and PR
- How much
- 8160 bottles
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmac
D-0159-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
- Where it went
- USA Nationwide
- How much
- 3,888
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharma
D-0160-2025 · Class II · reported 2025-01-01 · Ongoing
- Why it was recalled
- CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
- Where it went
- USA Nationwide
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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