CLASS II ONGOING Drug recall · Reported 6 May 2026 · FDA Enforcement Report
Alendronate Sodium Oral Solution, 70 mg recalled
Hikma Pharmaceuticals USA is recalling Alendronate Sodium Oral Solution, 70 mg, distributed nationwide in the US. The recall was initiated on 7 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0526-2026
- FDA event ID
- 98744
- Recalling firm
- Hikma Pharmaceuticals USA, Columbus, OH
- Brand
- Alendronate Sodium
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Apr 2026
- FDA classified
- 8 May 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Apr 2026 | Recall initiated by company | |
| 6 May 2026 | Published in enforcement report | +29 days |
| 8 May 2026 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Which lots are affected?
Lot # AC2040A, Exp Date: 04/2026
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hikma Pharmaceuticals USA
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2mg/mL vial recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
Other Alendronate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alendronate Sodium Tablets, USP, 70 mg* blisters recalled | Sun Pharma Global Fze | Potency & Assay | Nationwide |