CPSC recall · Reported July 27, 2016
Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
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.
Novel Laboratories, of Somerset, N.j. recalled This recall involves 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tab….
Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-R… was recalled by Novel Laboratories, of Somerset, N.j. in July 27, 2016. Reason: The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging…. Remedy: Consumers should immediately stop using the recalled tablets and contact Novel Laboratori…. Verify recall #16232 with the CPSC before acting.
The recall
Novel Laboratories, of Somerset, N.j. issued this CPSC recall-The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging….
- None
- agency class
- July 27, 2016
- reported
Sourced from official CPSC enforcement records. Verify recall #16232 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. Consumers holding this product should act on the agency's documented remedy above rather than relying on general guidance.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Product 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.
Reason for recall
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, what to do
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Consumer Product Safety Commission |
| Severity class | Not classified by agency |
| Status | Active |
| Recall number | 16232 |
| Date reported | July 27, 2016 |
| Date initiated | July 27, 2016 |
| Recalling firm | Novel Laboratories, of Somerset, N.j. |
| Affected scope | About 5,700 boxes of 30 blister packs |
| Distribution | Not disclosed |
| Official source | CPSC notice → |
Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.
What to do with this recall
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full re…
- Check the recall number (16232) and product description against the item you own. Search the archive
- Confirm the current status and remedy on the official CPSC notice before acting. CPSC notice
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official CPSC record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Similar Drugs & Medications · nearest report date
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Methodology · Corrections · Archive as of August 2026