CLASS III Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report
Diazepam Rectal Gel, 2.5 mg recalled by Valeant Pharmaceuticals North
Valeant Pharmaceuticals North America is recalling Diazepam Rectal Gel, 2.5 mg, Twin Pack that Contains two pre-filled, unit-dose, rectal, distributed nationwide in the US. The recall was initiated on 10 Jul 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1041-2018
- FDA event ID
- 80662
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Brand
- Diazepam
- Manufacturer
- Oceanside Pharmaceuticals
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Jul 2018
- FDA classified
- 3 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 10 Jul 2018 | Recall initiated by company | |
| 3 Aug 2018 | Classified by FDA | +24 days |
| 15 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Product as listed by the FDA
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Which lots are affected?
Lot #: NBBN, Exp 02/22
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Valeant Pharmaceuticals North America
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl CD capsules, 360 mg recalled | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
Other Diazepam recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | diazePAM 5 MG/ML Injection Solution (C-iv) Syr per syringe recalled | RXQ Compounding | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection USP 10mg/ (5 mg/mL recalled by HospiraDiazepam | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Diazepam 5 mg/mL injectable recalled by Martin Avenue Pharmacy | Martin Avenue Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP, 5 mg/mL recalled by HospiraDiazepam | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injectable, compounded by Pallimed Solutions recalled | Pallimed Solutions | Sterility | Nationwide |