Tretinoin Capsules Recalled Nationwide for Failed Dissolution Specifications
Teva Pharmaceuticals is recalling Tretinoin Capsules (10 mg) nationwide due to failed dissolution specifications that may affect medication effectiveness. Patients should contact their pharmacist or doctor to confirm if their prescription is affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a prescription medication due to failed dissolution specifications, which could affect drug bioavailability and treatment effectiveness. No illnesses or injuries have been reported, but the quality defect poses a risk to proper medication treatment.
Plain-English summary
Teva Pharmaceuticals USA Inc. is recalling Tretinoin Capsules, 10 mg, due to failed dissolution specifications. The capsules may not dissolve properly in the body, which could affect how much medication is absorbed and the effectiveness of treatment.
The recall affects 4,941 bottles distributed nationwide in the United States. The affected lots are: Lot #100022971 (expiration 08/2022), Lot #100022972 (expiration 05/2023), and Lot #100028920 (expiration 09/2023). The product is identified by NDC 0555-0808-02 and comes in bottles of 100 capsules.
Patients currently taking this medication should contact their pharmacist or doctor to confirm whether their prescription is affected by this recall. Do not stop taking the medication without consulting your healthcare provider. Your doctor or pharmacist may recommend obtaining a replacement supply or switching to an alternative medication.
For more information about this recall, contact Teva Pharmaceuticals USA Inc. or visit the FDA's drug recalls webpage.
The recalled product
- Product
- Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 4,941
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 (6)
- Lot #s: 100022971
- Exp. 08/2022
- 100022972
- Exp. 05/2023
- 100028920
- Exp. 09/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva Pharmaceuticals USA Inc
See all →- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- 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 0.3 mg patches recalled over unapproved raw material use
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 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
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- ModerateTeva Recalls Dutasteride and Tamsulosin HCl Capsules for Dissolution Failures
FDA (Drugs) · 2017-11-08
- ModerateTeva Recalls Capecitabine Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2016-03-09
- HighTeva metoprolol succinate 100 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
- SevereAnagrelide Capsules Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2022-06-08
- HighTeva metoprolol succinate 50 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11