CLASS II Drug recall · Reported 6 Dec 2017 · FDA Enforcement Report
Levetiracetam Oral Solution, USP, 100 mg/mL recalled
Hetero Labs Ltd. - Unit III is recalling Levetiracetam Oral Solution, USP, 100 mg/mL, distributed in New Jersey. The recall was initiated on 12 Oct 2017 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-0099-2018
- FDA event ID
- 78287
- Recalling firm
- Hetero Labs Ltd. - Unit III, Hyderabad, N/A
- Brand
- Levetiracetam
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2017
- FDA classified
- 29 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 12 Oct 2017 | Recall initiated by company | |
| 29 Nov 2017 | Classified by FDA | +48 days |
| 6 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance (screw)
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
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47
Where it was distributed
NJ
Questions about this recall
Why was it recalled?
Presence of foreign substance (screw)
Which lots are affected?
Lot # E170346, Exp 02/19
Where was it sold?
NJ
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 Hetero Labs Ltd. - Unit III
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fenofibrate Tablets, USP 145 mg recalled by Hetero Labs, Ltd. - Unit IIIFenofibrate | Hetero Labs Ltd. - Unit III | Other | IN, LA |
| Drug | CLASS II | Indomethacin Capsules, USP, 50 mg recalledIndomethacin | Hetero Labs Ltd. - Unit III | Other | Nationwide |
| Drug | CLASS II | Aripiprazole Tablets, USP, 10 mg recalledAripiprazole | Hetero Labs Ltd. - Unit III | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS III | Simvastatin Tablets, USP, 40 mg recalled by Hetero Labs, Ltd. - Unit IIISimvastatin | Hetero Labs Ltd. - Unit III | Other | Nationwide |
Other Levetiracetam recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution 100 mg/mL (100 mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Levetiracetam Tablets USP, 250 mg UD recalled by McKesson | McKesson | Other | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution, 100 mg/mL recalled by Akorn | Akorn | Packaging Defects | Nationwide |
| Drug | CLASS II | Levetiracetam Tablets, USP 500 mg recalled by Eywa Pharma | Eywa Pharma | Packaging Defects | Nationwide |