Medications & Supplements/Prescription Drugs

AvKARE Chlorpromazine Hydrochloride Tablets Recalled for Foreign Substance

Agency Publication Date: September 11, 2025

Summary

AvKARE is recalling approximately 3,515 cartons of Chlorpromazine Hydrochloride tablets (50 mg and 100 mg) because a foreign substance was found in the product. Chlorpromazine (chlorproMAZINE) is a prescription antipsychotic medication used to treat certain mental or mood disorders. This recall affects unit dose cartons distributed nationwide across the United States. If you are taking this medication, you should consult your healthcare provider or pharmacist regarding the recall and any potential health concerns.

Risk

The presence of a foreign substance in medication can lead to unexpected side effects, allergic reactions, or reduced effectiveness of the treatment. While no specific injuries or incidents were reported in the data, the presence of unidentified materials in a pharmaceutical product poses a safety risk to patients.

What You Should Do

Check your medication packaging for the following NDC codes: 50268-164-15 (50 mg) or 50268-165-15 (100 mg).
For the 50 mg tablets (NDC 50268-164-15), look for lot 46824 with expiration date 9/30/25, or lot 47171 with expiration date 12/31/25.
For the 100 mg tablets (NDC 50268-165-15), look for lot 47089 with expiration date 12/31/25, or lot 47604 with expiration date 03/31/26.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton

Variants: 50 mg, Tablet

Lot Numbers:

46824 (Exp 9/30/25)

47171 (Exp 12/31/25)

NDC:

50268-164-15

Recall #: D-0643-2025; Manufactured for AvKare, Pulaski, TN.

Product: chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton

Variants: 100 mg, Tablet

Lot Numbers:

47089 (Exp 12/31/25)

47604 (Exp 03/31/26)

NDC:

50268-165-15

Recall #: D-0644-2025; Manufactured for AvKare, Pulaski, TN.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97548

Status: Active

Manufacturer: AvKARE

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 2 products (1512 cartons; 2003 cartons)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication packaging for the following NDC codes: 50268-164-15 (50 mg) or 50268-165-15 (100 mg).

For the 50 mg tablets (NDC 50268-164-15), look for lot 46824 with expiration date 9/30/25, or lot 47171 with expiration date 12/31/25.

For the 100 mg tablets (NDC 50268-165-15), look for lot 47089 with expiration date 12/31/25, or lot 47604 with expiration date 03/31/26.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton

Variants: 50 mg, Tablet

Lot Numbers:

46824 (Exp 9/30/25)

47171 (Exp 12/31/25)

NDC:

50268-164-15

Recall #: D-0643-2025; Manufactured for AvKare, Pulaski, TN.

Product: chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton

Variants: 100 mg, Tablet

Lot Numbers:

47089 (Exp 12/31/25)

47604 (Exp 03/31/26)

NDC:

50268-165-15

Recall #: D-0644-2025; Manufactured for AvKare, Pulaski, TN.