Severity
Moderate
ModerateActive
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… - a moderate-severity action.
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 moderate-severity CPSC recall-The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging….
- Moderate
- severity level
- 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 CPSC action (record #16232) was formally reported on July 27, 2016. It is classified under Moderate severity, with a current status of Active. Novel Laboratories, of Somerset, N.j. is listed as the recalling firm. Federal records list the affected scope as About 5,700 boxes of 30 blister packs.
The documented reason for this recall is: 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. Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. The remedy documented by the agency is: Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund. - consumers holding this product should act on that instruction 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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
About 5,700 boxes of 30 blister packs
Related Recalls
6
0 from same agency
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 | Moderate |
| 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.
Frequently Asked Questions
What product was 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.. Recalled by Novel Laboratories, of Somerset, N.j.. Units affected: About 5,700 boxes of 30 blister packs.
Why was this product 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.
What should consumers do? ▼
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
Which agency issued this recall? ▼
This recall was issued by the CPSC on July 27, 2016. Severity: Moderate. Recall number: 16232.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (16232) against your product. Visit the official CPSC website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
How do I report an injury from a recalled product? ▼
Report injuries to the issuing agency: CPSC at SaferProducts.gov, NHTSA at nhtsa.gov/report-a-safety-problem, or FDA via MedWatch. Document the product (photos, model/serial numbers, purchase receipts) and seek medical attention. Injury reports help agencies track hazard patterns and may strengthen enforcement actions.
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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: CPSC, reported July 27, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.