Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
CPSC recall 16232. Recall date: .
Hazard, in the words of CPSC
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.
Remedy, in the words of CPSC
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
CPSC recall 16232 has the recall date 27 Jul 2016. The notice names the firm Novel Laboratories. The recall has about 5,700 units. The median CPSC recall of 2016 has 6,400 units. This register puts the recall under the hazard Poisoning. CPSC gives the product type Tablet or Capsule Drugs.
Federal law prohibits any person from selling products subject to a Commission ordered recall or a voluntary recall undertaken in consultation with the CPSC.
CPSC publishes these words. Source: CPSC recall notices, section About the U.S. CPSC, read on . The hazard, the remedy and the incident text on this site are the words of the CPSC recall notice. Newest CPSC recall on the register: .
More of the notice
The hazard and the remedy are at the top of the page. Each quotation is the text of CPSC.
| Incidents and injuries | None reported |
|---|---|
| Units | 5,700 |
| Remedy options | Refund |
| Description | 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. |
| Product | Zolpidem Tartrate Sublingual tablets, About 5,700 boxes of 30 blister packs, Tablet or Capsule Drugs |
| Sold at | 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. |
| Manufacturer | Novel Laboratories |
| Distributor | Gavis Pharmaceuticals |
| Made in | United States |
Recall notice: The page that CPSC publishes for one recall of a consumer product. It states the product, the hazard, the remedy and the incidents.
Hazard: The way a product can cause harm, in the words of the CPSC recall notice. This site also puts each recall under short hazard names.
Remedy: What the manufacturer or the firm does about a recalled product. The agency record states the remedy of each recall.
Units: The number of vehicles or products that a recall can include. The manufacturer or the firm reports the number to the agency.
- Hazard: Poisoning
- Category: Tablet or Capsule Drugs
- CPSC recalls of 2016
The recall in context
- Units in this recall
- 5,700Median of 2016: 6,400
- CPSC recalls of 2016
- 330
- Recalls of 2016 with one of the same hazards
- 4%
- Recalls of 2016 in the category Tablet or Capsule Drugs
- 0%
- Recalls on the register that name Novel Laboratories
- 1
Official channels
- CPSC recall notice 16232The notice on the CPSC site, with the pictures and the contact of the firm.
- CPSC recallsThe list of all recall notices on the CPSC site.
- SaferProducts.govThe CPSC site for a report about a consumer product.
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Cite this page
Recall Register. CPSC recall 16232. https://recallregister.com/product/7814-novel-laboratories-recalls-zolpidem-tartrate-blister-packs-due-to-fail/. Source: CPSC Recall Retrieval Web Services. Data through .
Sources
- Source
- US Consumer Product Safety Commission
- Licence
- US government work, public domain
- Data retrieved
- 30 Sep 2026
- Newest CPSC recall on the register
- 24 Sep 2026
The CPSC notice is the authority. The hazard names come from the hazard text of CPSC. The category is the product type that CPSC gives. How the register is made. Report an error.
Questions
- Does CPSC recall 16232 report injuries?
- The CPSC notice says:
None reported
- Where was the product sold?
- The CPSC notice says:
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.
- Which remedy options does CPSC list for recall 16232?
- CPSC lists 1 remedy option:
Refund
- How many units are in CPSC recall 16232?
- The CPSC notice gives this number:
About 5,700 boxes of 30 blister packs