CLASS II Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Zolpidem Tartrate Extended-Release Tablets, USP 25 mg recalled
Sun Pharmaceutical Industries is recalling Zolpidem Tartrate Extended-Release Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0271-2024
- FDA event ID
- 93820
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Brand
- Zolpidem Tartrate
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 18 Jan 2024
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Anxiety & Sleep Medication
Timeline
| 18 Jan 2024 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +7 days |
| 31 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Zolpidem Tartrate Extended-Release Tablets, USP 25 mg recalled?
Yes. Sun Pharmaceutical Industries recalled Zolpidem Tartrate Extended-Release Tablets, USP 25 mg on 18 Jan 2024. The recall is Class II and its status is Completed. Recall number D-0271-2024.
Why was it recalled?
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Which lots are affected?
Lot #: DNE0892A Exp. 07/31/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Zolpidem recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zolpidem Tartrate Extended-Release Tablets, USP 5mg recalledZolpidem Tartrate | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Zolpidem Tartrate Tablets, CIV recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zolpidem Tartrate Tablets, CIV recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zolpidem Tartrate Tablets 5 mg per blister, 10 blisters recalled | American Health Packaging | Packaging Defects | Nationwide |