Purdue Pharma Recalls Intermezzo Tablets for Dissolution Failures
Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- 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
Similar recalls
- LowPurdue Pharma Recalls Intermezzo Sublingual Tablets for Dissolution Failures
FDA (Drugs) · 2015-07-29
- ModerateNifedipine Extended-Release Tablets Recall for Failed Dissolution
FDA (Drugs) · 2021-07-21
- ModerateTorrent Pharma Recalls Carbamazepine Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2020-06-10
- ModerateCarbamazepine tablets recalled for failed dissolution specifications
FDA (Drugs) · 2022-01-19
- ModerateTolterodine Tartrate Extended-Release Capsules Recalled for Failed Dissolution
FDA (Drugs) · 2025-04-09
- ModerateZydus Recalls Lansoprazole Tablets for Failed Dissolution Specification
FDA (Drugs) · 2020-11-11