Not Yet Classified

This recall has not yet been classified by risk level.

Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning

Date: July 27, 2016
Company: Novel Laboratories, of Somerset, N.J.
Status: Ongoing
Source: CPSC

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund. Options: Refund

Affected Products

This recall involves 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tablets from Novel Laboratories. The prescription medication is a sleep drug. The packaging for the 1.75 mg tablets has lot number M16140A, 1.75 mg and national drug code (NDC) 43386-762-30. The packaging for the 3.5 mg tablets has lot number M16144A, 3.5mg and national drug code (NDC) 43386-761-30. The Zolpidem Tartrate is packaged as a single tablet in a peel-and-push blister pack inside an outer open-ended pouch with 30 pouches per box. The lot number and an expiration date of 02/2018 are printed on the bottom left of the pouches. The NDC is printed on the top left corner of the boxes. "Gavis" is printed in blue on the center of the white boxes and pouches.

Why Was This Recalled?

The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by children.

Where Was This Sold?

Distribution information not available.

About Novel Laboratories, of Somerset, N.J.

Novel Laboratories, of Somerset, N.J. has 1 total recall tracked by RecallDetector.

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Data sourced from the CPSC. Last updated March 26, 2026. View original report