Why it was recalled
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Product description
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
Lot numbers, UPCs & expiration codes
Lot # AC2040A, Exp Date: 04/2026
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0526-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 7, 2026
- FDA report date
- May 6, 2026
- Quantity
- 4 single dose 75 ml bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA INC
Original FDA data
Every field from FDA enforcement report D-0526-2026, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 98744
- Address
- 1809 Wilson Rd
- Code information
- Lot # AC2040A, Exp Date: 04/2026
- Postal code
- 43228-9579
- Report date
- May 6, 2026
- Product type
- Drugs
- Recall number
- D-0526-2026
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA INC
- Product quantity
- 4 single dose 75 ml bottles
- Reason for recall
- This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Apr 7, 2026
- Initial firm notification
- Letter
- Center classification date
- May 8, 2026