Alendronate Sodium Oral Solution recall
FDA recall D-0526-2026 · initiated Apr 7, 2026
Hikma Pharmaceuticals USA INC recalled Alendronate Sodium Oral Solution in Apr 2026 — an FDA Class II recall (D-0526-2026) because This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4 single dose 75 ml bottles
Details
- Product
- 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.
- Recalling company
- Hikma Intl Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Apr 7, 2026
- FDA report date
- May 6, 2026
Frequently asked
- Was Alendronate Sodium Oral Solution recalled?
- Hikma Pharmaceuticals USA INC recalled Alendronate Sodium Oral Solution in Apr 2026 — an FDA Class II recall (D-0526-2026) because This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Alendronate Sodium Oral Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0526-2026 was: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- Is a recalled Alendronate Sodium Oral Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Alendronate Sodium Oral Solution are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # AC2040A, Exp Date: 04/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0526-2026.