Teva Recalls Actiq Fentanyl Lozenges Due to Dissolution Failure
Teva Pharmaceuticals is recalling 316 cartons of Actiq 200 mcg fentanyl lozenges because they failed dissolution specifications during stability testing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant potential health risks, such as failure to meet dissolution specifications for a potent opioid medication.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 316 cartons of Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick. The affected product includes single blisters (NDC 63459-502-01) and 30-count cartons (NDC 63459-502-30). The specific lot number is C88583, with an expiration date of 06/15. The product was manufactured by Cephalon, Inc., in Salt Lake City, Utah.
The recall was initiated because the product failed dissolution specifications during stability testing. This indicates that the medication may not release the active ingredient at the intended rate, potentially affecting its efficacy or safety profile.
The product was distributed within the United States to Florida, Illinois, Massachusetts, Missouri, Mississippi, Ohio, and Texas. There was no distribution to government or foreign entities. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on replacement or disposal.
The recalled product
- Product
- Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Opioid Analgesic
- Hazard
- Affected units
- 316
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 C88583
- exp. 06/15
Distribution
Related recalls
Same manufacturer · Teva Pharmaceuticals USA, Inc.
See all →- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.2 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 30 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
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