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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

Alendronate Sodium Oral Solution Recalled for Potential Potency Issues

Agency Publication Date: April 29, 2026
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Summary

Hikma Pharmaceuticals USA INC is recalling Alendronate Sodium Oral Solution (70 mg/75 mL), a prescription medication used to treat bone loss. The recall was initiated because certain bottles stored on their side during testing showed out-of-specification assay results, meaning the drug's potency or composition might not meet safety standards. Consumers who have this medication should check their bottles for specific lot numbers and expiration dates to see if their medicine is affected.

Risk

The drug may not contain the correct amount of active ingredient due to being stored on its side, which can lead to reduced effectiveness of the treatment for bone loss or other complications. No injuries or incidents have been reported to date.

What You Should Do

  1. Check your medication bottle for Alendronate Sodium Oral Solution, 70 mg/75 mL with NDC 0054-0282-59.
  2. Locate the lot number and expiration date on the packaging to see if it matches Lot # AC2040A with an expiration date of 04/2026.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Alendronate Sodium Oral Solution (75 mL)
Variants: 70 mg/75 mL, Oral Solution, Rx only
Lot Numbers:
AC2040A (Exp 04/2026)
NDC:
0054-0282-59

4 x 75 mL Single Dose Bottles per pack. Distributed by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98744
Status: Active
Manufacturer: Hikma Pharmaceuticals USA INC
Sold By: Wholesalers; Pharmacies
Manufactured In: United States
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.