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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Mixed Amphetamine Salt Tablets Recalled for Potential Mixed Strengths

Agency Publication Date: June 4, 2020
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Summary

Teva Pharmaceuticals USA has recalled approximately 158,837 bottles of various strengths of Mixed Amphetamine Salt Tablets (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate) because some bottles may contain tablets of a different strength than what is listed on the label. This recall affects 5 mg, 15 mg, and 20 mg strengths distributed nationwide in the United States and Puerto Rico. Taking a higher or lower dose than prescribed could result in a lack of efficacy or unexpected side effects, and consumers should immediately verify their medication against the provided lot numbers.

Risk

If a bottle contains tablets of an incorrect strength, a patient may inadvertently take more or less medication than prescribed by their doctor, which can lead to serious health consequences, especially for medications used to treat ADHD and narcolepsy.

What You Should Do

  1. Check your prescription bottle for the following specific identifying details: Mixed Amphetamine Salts 5 mg (NDC 0555-0971-02), 15 mg (NDC 0555-0777-02), or 20 mg (NDC 0555-0973-02).
  2. Verify the lot number and expiration date on the side of your bottle. Affected lots include: 42614718 (Exp. 02/2021) for 5 mg; 42617008 (Exp. 10/2021) for 15 mg; and 42617891 (Exp. 01/2022) for 20 mg.
  3. If your medication matches the affected lot numbers, contact your healthcare provider or pharmacist immediately to discuss your treatment and arrange for a safe replacement.
  4. Return any unused or affected medication to the pharmacy where you purchased it for a refund and further instructions.
  5. Contact Teva Pharmaceuticals USA at their distributor office in Parsippany, New Jersey, for more information regarding this voluntary recall.
  6. For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return unused product for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Mixed Amphetamine Salts Product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate), 5 mg (100 count bottles)
Model:
NDC 0555-0971-02
Recall #: D-1285-2020
Lot Numbers:
42614718 (Exp. 02/2021)
Date Ranges: 02/2021
Product: Mixed Amphetamine Salts Product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate), 15 mg (100 count bottles)
Model:
NDC 0555-0777-02
Recall #: D-1286-2020
Lot Numbers:
42617008 (Exp. 10/2021)
Date Ranges: 10/2021
Product: Mixed Amphetamine Salts Product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate), 20 mg (100 count bottles)
Model:
NDC 0555-0973-02
Recall #: D-1287-2020
Lot Numbers:
42617891 (Exp. 01/2022)
Date Ranges: 01/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85712
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies nationwide
Manufactured In: United States
Units Affected: 3 products (33,280 bottles; 41,348 bottles; 84,209 bottles)
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 ยท 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.