Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Is Zolpidem recalled?
Not under an active recall.
Zolpidem was recalled 10 times in the past — all now closed. Most recent: Jan 18, 2024.
Most common reason: cGMP deviation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zolpidem. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Zolpidem recalls on record
none so far in 2026; 10 on record, newest first
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Zolpidem Tartrate Sublingual Tablet 3.5 Mg 30 Unit Dose Pouches
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Intermezzo
Failed Dissolution Specifications
Class III · Low risk
Intermezzo
Failed dissolution specifications
Class II · Moderate risk
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zolpidem Tartrate
Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD22861_7, EXP: 5/8/2014.
Class II · Moderate risk
Zolpidem Tartrate Tablets 5 mg
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Class II · Moderate risk
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
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