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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Precision Dose Inc.: Carbamazepine Oral Suspension Recalled for Low Potency

Agency Publication Date: November 1, 2017
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Summary

Precision Dose Inc. has recalled 801 cases of Carbamazepine Oral Suspension USP (100 mg/5 mL) because the medication was found to be subpotent, meaning it contains less active ingredient than required. This prescription medication, used primarily for treating seizures and certain types of nerve pain, was distributed in 5 mL unit dose cups across the United States. If you or a family member use this medication, check your supply immediately to see if it is part of the affected lot to ensure you are receiving the correct dosage for your condition.

Risk

Subpotent medication may not provide the intended therapeutic effect, which could lead to breakthrough seizures or a return of symptoms in patients being treated for epilepsy or chronic pain. No injuries or adverse events have been reported in the provided data.

What You Should Do

  1. Check your medication packaging for Carbamazepine Oral Suspension USP, 100 mg/5 mL in 5 mL Unit Dose Cups with NDC 68094-301-59 (individual cups) or NDC 68094-301-62 (cases).
  2. Look for lot number 500105 with an expiration date of 04/30/18 printed on the packaging.
  3. If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement.
  4. Return any unused product to your pharmacy for a refund and to ensure the subpotent medication is properly handled.
  5. Contact Precision Dose Inc. at their South Beloit, Illinois location for further instructions regarding this recall.
  6. For additional questions, 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

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups
Model:
NDC 68094-301-59
NDC 68094-301-62
Recall #: D-0057-2018
Lot Numbers:
500105 (Exp 04/30/18)
Date Ranges: Expiration date 04/30/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78359
Status: Resolved
Manufacturer: Precision Dose Inc.
Sold By: pharmacies; hospitals
Manufactured In: United States
Units Affected: 801 cases
Distributed To: Nationwide

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.