US Drug Recall Register

FDA Drug Recalls

1,709 recalls · Class III, newest first

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

Fexofenadine Hydrochloride Tablets

Reason Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-547-20 D-1083-2015
Class III · Low risk Terminated

Cartia XT

Reason Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell

Actavis Laboratories, FL, Inc. NDC 62037-0600-90 D-0488-2015
Class III · Low risk Terminated

Promethazine Vc With Codeine Syrup

Reason Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

Qualitest Pharmaceuticals NDC 0603-1588-54 D00432-2015
Class III · Low risk Terminated

Fluorescein Sodium Ophthalmic Strips USP

Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.

Nomax Inc NDC 17478-404-01 D-0963-2015
Class III · Low risk Terminated

Rose Bengal GloStrips

Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.

Nomax Inc NDC 51801-004-01 D-0962-2015
Class III · Low risk Terminated

Fluorescein Sodium Ophthalmic Strips USP

Reason Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.

Nomax Inc NDC 51801-003-01 D-0961-2015
Class III · Low risk Terminated

Fexofenadine HCl Tablets

Reason Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Mylan Pharmaceuticals Inc. NDC 0378-0781-91 D-0435-2015
Class III · Low risk Terminated

Air Compressed

Reason Failed Impurities/Degradation Specification; out of specification results for carbon dioxide

Matheson, Inc. D-0423-2015
Class III · Low risk Terminated

Quinapril Tablets USP

Reason Subpotent Drug

AVKARE Inc. NDC 50268-691-15 D-0402-2015
Class III · Low risk Terminated

Quinapril Tablets USP

Reason Subpotent Drug

AVKARE Inc. NDC 50268-688-15 D-0401-2015
Class III · Low risk Terminated

Oxecta

Reason Failed Impurities/Degradation Specifications

Pfizer Inc. NDC 60793-526-01 D-0404-2015
Class III · Low risk Terminated

Oxecta

Reason Failed Impurities/Degradation Specifications

Pfizer Inc. NDC 60793-525-01 D-0403-2015
Class III · Low risk Terminated

Fentanyl Citrate Inj.

Reason Failed Impurities/Degradation Specifications; 12 month stability testing.

West-Ward Pharmaceutical Corporation NDC 0641-6028-25 D-0420-2015
Class III · Low risk Terminated

Bromfenac Ophthalmic Solution 0.09%

Reason CGMP Deviations: Product excipient was not re-tested at the appropriate date.

Apotex Inc. D-0487-2015
Class III · Low risk Terminated

Z-Cote Hp 1 Transparent Zinc Oxide

Reason Labeling: Illegible label. Writing is rubbing off of labels.

Nanophase Technologies Corporation D-0400-2015
Class III · Low risk Terminated

DOXOrubicin Hydrochloride Injection

Reason Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL

Mylan Institutional LLC NDC 53150-317-01 D-0412-2015
Class III · Low risk Terminated

Nicardipine Hydrochloride Injection

Reason Subpotent Drug and Failed Impurities/Degradation Specifications

Mylan Institutional LLC NDC 67457-224-10 D-0413-2015
Class III · Low risk Terminated

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP

Reason Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

Qualitest Pharmaceuticals NDC 0603-9013-54 D-0331-2015
Class III · Low risk Terminated

3M ESPE Clinpro 5000

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

3M Company/3m Espe Dental Products NDC 48878-3130-04 D-0376-2015
Class III · Low risk Terminated

Triamcinolone Acetonide Lotion USP

Reason Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

Akorn, Inc. NDC 61748-219-60 D-0333-2015
Class III · Low risk Terminated

sulfur8

Reason Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.

J. Strickland and Co D-0318-2015
Class III · Low risk Terminated

Belviq¿

Reason Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.

Eisai Inc D-0302-2015
Class III · Low risk Terminated

Fluoxetine Capsules USP

Reason Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Sandoz Incorporated NDC 0781-2822-01 D-0291-2015