Medications & Supplements/Prescription Drugs

Teva Amphetamine Mixed Salts Tablets Recalled for Mislabeled Strength

Agency Publication Date: September 13, 2022

Summary

Teva Pharmaceuticals USA Inc. has recalled 83,703 bottles of Amphetamine Mixed Salts tablets (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate). The recall was issued because a sealed 100-count bottle labeled as 15 mg strength actually contained 100 tablets of 20 mg strength. No incidents or injuries have been reported to date.

Risk

Patients who unknowingly take a 20 mg tablet instead of the prescribed 15 mg dose may experience adverse effects or complications from a higher-than-intended dosage of stimulant medication.

What You Should Do

This recall affects 100-count bottles of Teva Amphetamine Mixed Salts Tablets (Mixed Salts of a Single Entity Amphetamine Product) labeled as 15 mg with NDC 0555-0777-02, specifically Lot 100023340 with an expiration date of 10/2024.
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 information.

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: Amphetamine Mixed Salts (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate) Tabletsby Teva

Variants: 15 mg (labeled), 20 mg (actual), 100 tablets per bottle, Rx Only

Lot Numbers:

100023340 (Exp 10/2024)

NDC:

0555-0777-02

Firm initiated recall due to labeling error on declared strength.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90803

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 83,703 bottles

Distributed To: Nationwide

Agency Last Updated: September 16, 2022

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

What You Should Do

This recall affects 100-count bottles of Teva Amphetamine Mixed Salts Tablets (Mixed Salts of a Single Entity Amphetamine Product) labeled as 15 mg with NDC 0555-0777-02, specifically Lot 100023340 with an expiration date of 10/2024.

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 information.

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: Amphetamine Mixed Salts (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate) Tabletsby Teva

Variants: 15 mg (labeled), 20 mg (actual), 100 tablets per bottle, Rx Only

Lot Numbers:

100023340 (Exp 10/2024)

NDC:

0555-0777-02

Firm initiated recall due to labeling error on declared strength.