Zolpidem recalls

The FDA has published 5 recalls involving Zolpidem since 2014. The latest was reported on 31 Jan 2024. Most were for manufacturing (cgmp) deviations. SUN Pharmaceutical Industries 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 recalls5since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 31 Jan 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why zolpidem is recalled

Companies

By year

2024240%
2015240%
2014120%

All zolpidem recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
31 Jan 2024Drug	CLASS II	Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg recalledZolpidem Tartrate	SUN Pharmaceutical Industries	Sterility	Nationwide
31 Jan 2024Drug	CLASS II	Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg recalledZolpidem Tartrate	SUN Pharmaceutical Industries	Sterility	Nationwide
29 Jul 2015Drug	CLASS II	Zolpidem Tartrate Tablets, CIV recalled by Wockhardt Usa	Wockhardt Usa	Manufacturing (CGMP) Deviations	Nationwide
29 Jul 2015Drug	CLASS II	Zolpidem Tartrate Tablets, CIV recalled by Wockhardt Usa	Wockhardt Usa	Manufacturing (CGMP) Deviations	Nationwide
22 Jan 2014Drug	CLASS II	Zolpidem Tartrate, Tablet, 2.5 mg (1/2 of 5 mg) recalled	Aidapak Services	Labeling Errors	4 states

Should you stop taking Zolpidem?

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.