CLASS III ONGOING Drug recall · Reported 10 Jul 2024 · FDA Enforcement Report
Eszopiclone Tablets, USP 1mg CIV recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Eszopiclone Tablets, USP 1mg CIV, distributed in Mississippi, Ohio. The recall was initiated on 4 Jun 2024 and the FDA has classified it as Class III.
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-0581-2024
- FDA event ID
- 94754
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Eszopiclone
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 4 Jun 2024
- FDA classified
- 2 Jul 2024
- Reported
- 10 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 4 Jun 2024 | Recall initiated by company | |
| 2 Jul 2024 | Classified by FDA | +28 days |
| 10 Jul 2024 | 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
Failed Impurities/Degradation Specifications: Related Substances
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
Where it was distributed
OH, MS
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Related Substances
Which lots are affected?
Lot#: C2302598, Exp 2/29/2025
Where was it sold?
OH, MS
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Eszopiclone recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Eszopiclone, Tablet, 3 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |