Valeant Recalls Diazepam Rectal Gel Due to Missing Lot and Expiration Dates
Valeant Pharmaceuticals is recalling 306 cartons of Diazepam Rectal Gel because the outer cartons are missing lot numbers and expiration dates.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or manufacturing regulations that is not likely to cause adverse health consequences. The hazard is limited to missing documentation on the packaging.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 306 cartons of Diazepam Rectal Gel, 2.5 mg, TWIN PACK. The product is a prescription-only medication manufactured for Oceanside Pharmaceuticals and distributed nationwide in the USA. The specific lot affected is NBBN with an expiration date of 02/22.
The recall was initiated because the product was distributed without a lot number or expiration date on the outer carton. This labeling error prevents proper identification and tracking of the specific product units.
Consumers and healthcare providers should check their inventory for Diazepam Rectal Gel, 2.5 mg, TWIN PACK (NDC 68682-650-20) with Lot NBBN and Exp 02/22. If the outer carton is missing these identifiers, the product should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- DIAZEPAM (DIAZEPAM)
- Brand
- DIAZEPAM
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 306
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 #: NBBN
- Exp 02/22
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DIAZEPAM
- SevereHospira Recalls Diazepam Injection Due to Crystallized Active Ingredient
FDA (Drugs) · 2016-07-20
- SevereHospira Recalls Diazepam Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-09-04
- SevereHospira Recalls Diazepam Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereHospira Recalls Diazepam Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-05-15
- SevereHospira Recalls Diazepam Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-05-08
Same manufacturer · Valeant Pharmaceuticals North America LLC
See all →- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- LowValeant Recalls Diltiazem HCl Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowLegacy Pharmaceutical Packaging Recalls Lorazepam Tablets Due to Labeling Errors
FDA (Drugs) · 2013-06-12
- LowValeant Recalls Vasotec Tablets Due to Incorrect Package Insert Labeling
FDA (Drugs) · 2014-10-22
- LowValeant Recalls Diltiazem HCl Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- SevereAmneal Recalls Lorazepam Oral Concentrate Due to Defective Dropper Markings
FDA (Drugs) · 2017-12-27
- ModerateAidapak Recalls Exemestane Tablets Due to Potential Labeling Error
FDA (Drugs) · 2014-01-29
- LowVaseretic Tablets Recalled for Incorrect Package Insert Version
FDA (Drugs) · 2014-10-22