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Drug FDA Class II Ongoing Foreign material

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15

AvKARE Published Sep 17, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact AvKARE or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of a foreign substance.

Hazards

Foreign Substance · primary

Affected products (1)

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15

CHLORPROMAZINE HYDROCHLORIDE · 1512 cartons

NDC: 50268-162, 50268-163, 50268-164, 50268-165, 50268-166, 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
Lot codes: 46824
Code info: Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 25, 2025
  2. Published
    Sep 17, 2025
Recall number
D-0643-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.