US Drug Recall Register

FDA Drug Recalls

1,523 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class III · Low risk Terminated

Acetasol HC

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).

Actavis Inc NDC 0472-0882-82 D-1471-2016
Class III · Low risk Terminated

Desoximetasone Gel USP

Reason Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

Akorn, Inc. NDC 61748-205-60 D-1469-2016
Class III · Low risk Terminated

Children's Qnasl 40 mcg

Reason Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Teva North America NDC 59310-206-08 D-1453-2016
Class III · Low risk Terminated

5% Lidocaine HCL and 7.5% Dextrose Injection

Reason Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.

Hospira Inc. NDC 0409-4712-01 D-0169-2017
Class III · Low risk Terminated

DULOXETINE Delayed-Release Capsules

Reason Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018

Golden State Medical Supply Inc. NDC 60429-166-10 D-1255-2016
Class III · Low risk Terminated

Carvediol Tablets

Reason Failed Impurities/Degradation Specifications

Sun Pharmaceutical Industries, Inc. NDC 57664-247-88 D-1507-2016
Class III · Low risk Terminated

Carvediol Tablets

Reason Failed Impurities/Degradation Specifications

Sun Pharmaceutical Industries, Inc. NDC 57664-245-13 D-1506-2016
Class III · Low risk Terminated

Carvediol Tablets

Reason Failed Impurities/Degradation Specifications

Sun Pharmaceutical Industries, Inc. NDC 57664-244-18 D-1505-2016
Class III · Low risk Terminated

Carvediol Tablets

Reason Failed Impurities/Degradation Specifications

Sun Pharmaceutical Industries, Inc. NDC 57664-242-88 D-1504-2016
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 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 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