Unrated Drug recall · FDA · Published August 25, 2025

AvKARE ChloroproMAZINE 50mg Tablets Recall: Foreign Substance Hazard

AvKARE recalls 50mg chloroproMAZINE hydrochloride tablets due to foreign substance presence. Rx-only medication with specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #D-0643-2025Drug AvKARE ›

Recall notice

Presence of a foreign substance.

Take action

Contact the company

Recalling firmAvKARE615 N 1st St · Pulaski, TN 38478-2403

✎ GovInfoNow plain-language explainer

AvKARE is recalling 50mg chloroproMAZINE hydrochloride tablets that contain a foreign substance. This could pose a risk to users, though the exact danger level isn't specified in the recall notice. Read more at govinfonow.com/recall/31857-avkare-chloropromazine-50mg-tablets-recall-foreign-substance-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/31857-avkare-chloropromazine-50mg-tablets-recall-foreign-substance-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0643-2025

Cite this page

“AvKARE ChloroproMAZINE 50mg Tablets Recall: Foreign Substance Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31857-avkare-chloropromazine-50mg-tablets-recall-foreign-substance-hazard. Based on FDA recall #D-0643-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0643-2025%22&limit=1).

AvKARE voluntarily recalled chloroproMAZINE Hydrochloride Tablets, USP, 50 mg due to the presence of a foreign substance, according to the FDA. The recall was announced on August 25, 2025.

How to tell if you have it

Brand: AvKARE
Product: chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton
NDC: 50268-164-15
Lot # 46824, Exp 9/30/25
Lot # 47171, Exp 12/31/25
Quantity: 1512 cartons
Distribution: USA Nationwide

The hazard

The recall is due to the presence of a foreign substance in the tablets, according to the FDA.

Context

GovInfoNow's records show AvKARE has 13 other recalls on record since March 28, 2024. Other recent recalls include the February 13, 2026 Amantadine Capsules Recall for failed dissolution specifications and the December 31, 2025 Rosuvastatin Tablets recall for a dissolution issue. Additional similar product recalls include the June 4, 2026 Amgen Corlanor tablets recalls due to foreign substance and the June 26, 2026 Bionpharma Divalproex Tablets recall for foreign tablets risk.

How to tell if you have this one

Check for the product name 'chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton'. Look for lot numbers 46824 (expiring 9/30/25) or 47171 (expiring 12/31/25).

Brand
AvKARE
Category
Drug

FDA recall event · 2 products

All 2 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
USA Nationwide
NDC
50268-162-11, 50268-162-15, 50268-163-11, 50268-163-15, 50268-164-11, 50268-164-15, 50268-165-11, 50268-165-15, 50268-166-11, 50268-166-12

Recall number	Product, codes & lots	Quantity
D-0643-2025	chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15; Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25	1512 cartons
D-0644-2025	chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15; Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26	2003 cartons

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, lot number, and expiration date to confirm if it's part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 23 days after the firm started it.

Aug 25, 2025Firm started the recall
Sep 11, 2025FDA classified it Class II
Sep 17, 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/31857-avkare-chloropromazine-50mg-tablets-recall-foreign-substance-hazard">AvKARE ChloroproMAZINE 50mg Tablets Recall: Foreign Substance Hazard (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-0643-2025 (August 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0643-2025 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.