Purdue Pharma Recalls Intermezzo Tablets for Dissolution Failures
Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The failure to meet dissolution specifications is a quality control issue that may affect efficacy but does not present an immediate safety hazard like contamination or mislabeling of allergens.
Plain-English summary
Purdue Pharma L.P. is recalling Intermezzo (zolpidem tartrate) sublingual tablets, 1.75 mg, 30-count cartons. The recall was initiated because the product failed to meet dissolution specifications.
The affected product is distributed in Florida, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, Ohio, and South Carolina. The specific lot number is 3126431B, with an expiration date of 09/30/17. A total of 2,172 cartons are involved in this recall.
Consumers should check their medication for the specific lot number and expiration date. If the product matches the recalled lot, they should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
- Manufacturer
- Purdue Pharma L.P.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,172
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3126431B
- Expiry: 09/30/17
Distribution
Related recalls
Same manufacturer · Purdue Pharma L.P.
See all →- LowPurdue Pharma Recalls Intermezzo Sublingual Tablets for Dissolution Failures
FDA (Drugs) · 2015-07-29
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17