Recall of Alendronate Sodium Oral Solution by Hikma Pharmaceuticals
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Hikma Pharmaceuticals USA Inc. is voluntarily recalling Alendronate Sodium Oral Solution due to out-of-specification assay results from improper storage, affecting products distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Hikma Pharmaceuticals USA Inc. is conducting a voluntary recall of Alendronate Sodium Oral Solution because of out-of-specification assay results in a limited number of bottles that were stored on their side.
Which Products Are Affected
The affected product is Alendronate Sodium Oral Solution, 70 mg/75 mL, in 4 single dose 75 mL bottles. It has NDC 0054-0282-59, UPC 0300540282592, Lot # AC2040A, and expiration date April 2026. The recall involves products distributed nationwide in the United States.
What You Should Do
Consumers should immediately stop using the affected product and contact Hikma Pharmaceuticals USA Inc. for instructions on returns or refunds. Reach out to the firm at 1809 Wilson Rd, Columbus, OH 43228-9579.
Why This Matters
This recall highlights potential quality issues with a prescription drug that could impact patient safety, as it is classified as a Class II recall, indicating possible temporary or reversible health consequences.
Source
FDA Recall Announcement for recall number D-0526-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,059 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.