Alendronate recalls

The FDA has published 2 recalls involving Alendronate since 2016. The latest was reported on 6 May 2026. Most were for potency & assay. Hikma Pharmaceuticals USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2016

Last 12 months1reported

Class I00% of total

Ongoing1latest 6 May 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why alendronate is recalled

Potency & Assay2100%

Companies

Hikma Pharmaceuticals USA150%
Sun Pharma Global Fze150%

By year

2026150%
2016150%

Ongoing alendronate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide

All alendronate recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
9 Mar 2016Drug	CLASS II	Alendronate Sodium Tablets, USP, 70 mg* blisters recalled	Sun Pharma Global Fze	Potency & Assay	Nationwide

Should you stop taking Alendronate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.