CLASS II Drug recall · Reported 13 Jul 2022 · FDA Enforcement Report
Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma Usa
Macleods Pharma Usa is recalling Eszopiclone Tablets, USP 1 mg, distributed nationwide in the US. The recall was initiated on 16 Jun 2022 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-1174-2022
- FDA event ID
- 90444
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Brand
- Eszopiclone
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2022
- FDA classified
- 5 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Anxiety & Sleep Medication
Timeline
| 16 Jun 2022 | Recall initiated by company | |
| 5 Jul 2022 | Classified by FDA | +19 days |
| 13 Jul 2022 | 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
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
Where it was distributed
Distributed Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Which lots are affected?
Lot #: BEK2009A Exp: 11/2023
Where was it sold?
Distributed Nationwide and Puerto Rico.
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 Macleods Pharma Usa
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Eszopiclone recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eszopiclone Tablets, USP 1mg CIV recalled by Dr. Reddy's LaboratoriesEszopiclone | Dr. Reddy's Laboratories | Potency & Assay | MS, OH |
| Drug | CLASS II | Eszopiclone, Tablet, 3 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |