CLASS II Drug recall · Reported 14 Nov 2012 · FDA Enforcement Report
Northstar Zolpidem Tartrate Tablets USP 10 mg recalled
Aurobindo Pharma is recalling Northstar Zolpidem Tartrate Tablets USP 10 mg, distributed nationwide in the US. The recall was initiated on 9 Mar 2012 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-041-2013
- FDA event ID
- 62113
- Recalling firm
- Aurobindo Pharma, Mehbubnagar, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2012
- FDA classified
- 6 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 9 Mar 2012 | Recall initiated by company | |
| 6 Nov 2012 | Classified by FDA | +242 days |
| 14 Nov 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Batch Number ZPSB11054-A Exp. 05/13
Where was it sold?
Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Metformin Hydrochloride Tablets, USP 1000 mg recalledMetformin Hydrochloride | Aurobindo Pharma | Other | Nationwide |
| Drug | CLASS I | Ampicillin and Sulbactam for Injection vial recalled by Aurobindo PharmaAmpicillin And Sulbactam | Aurobindo Pharma | Particulate Matter | Nationwide |