Hetero Labs, Ltd. - Unit III Levetiracetam Oral Solution Recall

Why it was recalled

Presence of foreign substance (screw)

Product description

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

Lot numbers, UPCs & expiration codes

Lot # E170346, Exp 02/19

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0099-2018
Classification: Class II
Status: Terminated
Recall initiated: Oct 12, 2017
FDA report date: Dec 6, 2017
Quantity: 4050 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Hetero Labs, Ltd. - Unit III

Original FDA data

Every field from FDA enforcement report D-0099-2018, exactly as published.

Show all FDA fields

City: Hyderabad
Status: Terminated
Country: India
Event ID: 78287
Address: Plot 22-110, Part Ii, Ida
Address (line 2): Rangareddy, Jeedimetla
Code information: Lot # E170346, Exp 02/19
Report date: Dec 6, 2017
Product type: Drugs
Recall number: D-0099-2018
Classification: Class II
Recalling firm: Hetero Labs, Ltd. - Unit III
Product quantity: 4050 bottles
Termination date: Sep 3, 2020
Reason for recall: Presence of foreign substance (screw)
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: NJ
Recall initiation date: Oct 12, 2017
Initial firm notification: Letter
Center classification date: Nov 29, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0099-2018, published Dec 6, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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