Class III
Terminated
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
- Recall Initiated
- June 5, 2014
- Posted
- November 5, 2014
- Recall Number
- D-0053-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 55,650 HDPE bottles
- Firm Location
- Bridgewater, NJ, United States
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Distribution
Nationwide
Lot / Code Info
Lot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073P; Exp. 09/15 13A036P; Exp. 11/15 13B035P; Exp. 11/15 13C046P; Exp. 11/15 13D060P; Exp. 11/15 13E030P; Exp. 03/16 13E031P; Exp. 03/16 13F003P; Exp. 03/16 13K034P; Exp. 03/16 14A001P; Exp. 10/16
More recalls by Valeant Pharmaceuticals North America Llc
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceut...
Feb 20, 2019 · Class III
Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant P...
Oct 31, 2018 · Class II
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery syst...
Aug 15, 2018 · Class III
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026