Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
Home product recall 16-232. Announced by CPSC on Jul 27, 2016.
- CPSC: stop using it
Watch and the shortlist are kept with a free account, on every device. Your watch list. CPSC’s own notice is on cpsc.gov.
The short answer
Announced by CPSC on Jul 27, 2016. Copied from CPSC on Oct 19, 2026.
- Stop using it what CPSC tells owners to do now (needs attention)
- Refund what’s offered
- About 5,700 boxes of 30 blister packs units, as CPSC gives them
- None injuries, CPSC’s notice says
Every line below is in CPSC’s own words, with its source beside it.
What’s wrong with it?
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.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
What should you do?
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
- What the company offers to fix a recalled product or vehicle: a repair, a replacement or a refund, as the recall notice says. For a vehicle, dealers make the safety repair free. Follow the notice’s own steps, or contact the company it names. Source: CPSC; NHTSA (49 U.S.C. 30120).: refund.
- How to reach the firm: Novel Laboratories toll-free at (866) 403-7592 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.novellabs.net and click on “Important Zolpidem Information” for more information.
Which ones are recalled?
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.
About 5,700 boxes of 30 blister packs units, as CPSC gives them.
Zolpidem Tartrate Sublingual tablets.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
Numbers to check against yours
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UPC
343386761012 -
UPC
343386762019
Copied exactly as CPSC lists them.
CPSC’s photos
CPSC shows 6 photos on its notice. Hearth Record doesn’t copy them; each opens on cpsc.gov.
- Novel Laboratories sleep tablets 1.75 mg box (front)
- Novel Laboratories sleep tablets 1.75 mg envelope (front)
- Novel Laboratories sleep tablets 1.75 mg envelope (back)
- Novel Laboratories sleep tablets 3.5 mg box (front)
- Novel Laboratories sleep tablets 3.5 mg envelope (front)
- Novel Laboratories sleep tablets 3.5 mg envelope (back)
Who made and sold it?
- Made by Novel Laboratories, Somerset, N.J.
- Distributed by Gavis Pharmaceuticals, Somerset, N.J.
- Clinics and pharmacies nationwide, including CVS, Costco, Walgreens, Kroger, and Wegmans from March 2016 through May 2016 for about $800 per box of 30 tablets.
- Made in United States, as the notice gives it.
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
Was anyone hurt?
None reported
CPSC, Recalls API. Checked Oct 19, 2026. Updated daily.
What the record doesn’t say
- The notice lists no model numbers in a field of their own; its description may give them.
- How many have been returned or fixed isn’t in the notice.
Hearth Record wrote these lines.
Sources
-
U.S. Consumer Product Safety Commission, Recalls API.
Checked Oct 19, 2026. Updated daily. Public domain (U.S. Government work). CPSC asks to be credited, and that no endorsement be implied.
Recalls of kids’ and home products are from the U.S. Consumer Product Safety Commission (CPSC). CPSC does not endorse Hearth Record. Copied on Oct 19, 2026.