ZOLPIDEM TARTRATE Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets pe Recall 2024
Official title: Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I
Verified source
U.S. Food and Drug Administration
This summary mirrors the official FDA notice issued January 18, 2024. Last synced from FDA: Apr 27, 2026.
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 19...
What's recalled
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lot #: DNE0892A Exp. 07/31/2026 |
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Where was it sold
Nationwide in the USA
What to do
- Do not consume or use this product
- Check the lot numbers or UPC codes listed above
- Return the product to the store where you purchased it for a full refund
- Contact your healthcare provider if you have experienced any symptoms
Common questions about this recall →
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Frequently Asked Questions
Is the ZOLPIDEM TARTRATE recall still active?
Yes, this recall is currently active as of January 18, 2024. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lot #: DNE0892A Exp. 07/31/2026. Check the label on your product.
What should I do if I have the recalled ZOLPIDEM TARTRATE?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.
Why was ZOLPIDEM TARTRATE recalled in 2024?
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.