Lower risk Drug recall · FDA · Published August 27, 2025

Chlorpromazine Tablets Recall: Foreign Substance in Packaging

Amerisource Health Services recalls chlorpromazine 200mg tablets due to a microorganism found in packaging material. No tablets were contaminated. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0650-2025Drug Amerisource Health Services ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmAmerisource Health Services LLC2550 John Glenn Ave Ste A · Columbus, OH 43217-1188

✎ GovInfoNow plain-language explainer

Amerisource Health Services is recalling chlorpromazine hydrochloride tablets that may contain a foreign substance in their packaging. This could pose a risk if the packaging is compromised, though the tablets themselves are not contaminated. Read more at govinfonow.com/recall/31830-chlorpromazine-tablets-recall-foreign-substance-in-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/31830-chlorpromazine-tablets-recall-foreign-substance-in-packaging · Updated August 17, 2026 · FDA enforcement record: FDA #D-0650-2025

Cite this page

“Chlorpromazine Tablets Recall: Foreign Substance in Packaging.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31830-chlorpromazine-tablets-recall-foreign-substance-in-packaging. Based on FDA recall #D-0650-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0650-2025%22&limit=1).

The FDA announced on August 27, 2025, that Amerisource Health Services LLC is recalling chlorproMAZINE Hydrochloride Tablets, USP, 200 mg due to the presence of a foreign substance. The recall involves 873 cartons distributed nationwide.

How to tell if you have it

Brand: Amerisource Health Services
Product: chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton
NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
Lot codes: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027
Quantity: 873 cartons

The hazard

A specific lot of auxiliary polyester coil used in product packaging was detected with the presence of a micro-organism. No micro-organism was detected on any tablets.

Context

GovInfoNow's records show Amerisource Health Services LLC has 30 other recalls on record since July 27, 2022. Other recent recalls of similar products include Amerisource Health Primidone Tablets Recall (May 1, 2026), Meclizine 12.5mg Tablets Recall (March 16, 2026), and Oxycodone 5mg Tablets Recall (January 14, 2026). Other recent recalls of similar products include Golden State Baclofen Tablets Recall (November 26, 2025), Amgen Recalls Corlanor 5mg Tablets Due to Foreign Substance (June 4, 2026), and Bionpharma Divalproex Tablets Recall (June 26, 2026).

How to tell if you have this one

Check for the NDC number 60687-463-01 (or 60687-463-11) and lot numbers 1021640 (expiring 10/31/2026) or 1022639 (expiring 01/31/2027) on the packaging.

Brand
Amerisource Health Services
Category
Drug

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA
NDC
60687-419-11, 60687-419-01, 60687-430-11, 60687-430-01, 60687-430-65, 60687-441-11, 60687-441-01, 60687-452-11, 60687-452-01, 60687-463-11, 60687-463-01

Recall number	Product, codes & lots	Quantity
D-0647-2025	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.; 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	2,708 cartons
D-0648-2025	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); Lot: 1022159, exp 12/31/2026; 1023299, exp 03/31/2027; 1024057, Exp 04/30/2027	1,062 cartons
D-0649-2025	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); Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027	1,757 cartons
D-0650-2025	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); Lot: 1021640, Exp 10/31/2026; 1022639, Exp 01/31/2027	873 cartons

Based on the official FDA remedy

What to do — step by step

Check Packaging Details
Look for NDC number 60687-463-01 or 60687-463-11 and lot numbers 1021640 or 1022639 on the blister pack.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 28 days after the firm started it.

Aug 27, 2025Firm started the recall
Sep 15, 2025FDA classified it Class II
Sep 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31830-chlorpromazine-tablets-recall-foreign-substance-in-packaging">Chlorpromazine Tablets Recall: Foreign Substance in Packaging (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0650-2025 (August 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0650-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.