CPSC recall 16232

Zolpidem Tartrate Sublingual tablets

• CPSC
• unknown
• Published 2016-07-27

On 2016-07-27 the CPSC announced a recall of Zolpidem Tartrate Sublingual tablets by Novel Laboratories, citing 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.

Read the official CPSC notice

Product

Zolpidem Tartrate Sublingual tablets | 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

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: unknown.

Source

Official record: https://www.cpsc.gov/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs

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