US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class III · Low risk Terminated

Methylprednisolone Tablets

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-003-14 D-0205-2017
Class III · Low risk Terminated

Seconal Sodium

Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

Valeant Pharmaceuticals North America LLC D-1059-2016
Class III · Low risk Terminated

Cyproheptadine Hydrochloride Syrup

Reason Subpotency: product assayed and found OOS for cyproheptadine

Lyne Laboratories, Inc. NDC 64980-0504-48 D-1062-2016
Class III · Low risk Terminated

Sirolimus Tablets

Reason Failed impurities/degradation: out of specification result for impurity secorapamycin.

Dr. Reddy's Laboratories, Inc. NDC 55111-653-01 D-1063-2016
Class III · Low risk Terminated

Urea

Reason Crystallization; complaints received by the manufacturer of crystals forming in product

Exact-Rx Inc NDC 42808-0200-05 D-1465-2016
Class III · Low risk Terminated

Ciprofloxacin OPTH 0.3% SOL

Reason Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

Aidarex Pharmaceuticals LLC D-1061-2016
Class II · Moderate risk Terminated

Chlorhexidine Gluco. 0.12% Oral Rinse

Reason Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

Aidarex Pharmaceuticals LLC D-0975-2016
Class III · Low risk Terminated

CEFTRIAXONE for Injection USP

Reason CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.

Aidarex Pharmaceuticals LLC NDC 53217-0117-01 D-0974-2016
Class III · Low risk Terminated

mitoXANTRONE Injection USP

Reason Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.

Teva North America NDC 0703-4685-01 D-1451-2016
Class III · Low risk Terminated

Irbesartan and Hydrochlorothiazide Tablets

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

Prinston Pharmaceutical Inc NDC 43547-331-09 D-1049-2016
Class III · Low risk Terminated

Pramipexole Dihydrochloride Extended Release Tablets

Reason Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.

Par Pharmaceutical NDC 10370-251-11 D-1038-2016
Class III · Low risk Terminated

Lisinopril Tablets USP

Reason Labeling: Incorrect or Missing Package Insert

Sandoz Inc NDC 0185-0630-01 D-1036-2016
Class III · Low risk Terminated

Lodrane D

Reason Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

Valeant Pharmaceuticals North America LLC D-1032-2016
Class II · Moderate risk Terminated

Nitrofurantoin Oral Suspension

Reason Failed Dissolution Specifications

Nostrum Laboratories, Inc. NDC 57664-239-32 D-1030-2016
Class III · Low risk Terminated

Oxycodone HCl

Reason Failed Impurities/Degradation Specification; 9 month stability

West-Ward Columbus Inc NDC 0054-0390-41 D-1441-2016
Class III · Low risk Terminated

Doxycycline

Reason Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.

Galderma Laboratories, L.P. D-1031-2016
Class III · Low risk Terminated

Mycophenolate Mofetil

Reason cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration

Attix Pharmaceuticals Inc D-1047-2016