US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

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

Anastrozole 0.5 mg Capsules

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

KRS Global Biotechnology, Inc D-0161-2018
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection

Reason Lack of Assurance of Sterility

Fresenius Medical Care Renal Therapies Group, LLC NDC 49230-0300-10 D-0827-2018
Class III · Low risk Terminated

Isradapine Capsules USP 2.5 mg

Reason Failed Impurities/Degradation Specifications

Elite Laboratories Inc. NDC 42806-263-01 D-0107-2018
Class III · Low risk Terminated

Fluconazole Injection

Reason Superpotent

Renaissance Lakewood, LLC NDC 33600-002-10 D-0124-2018
Class I · High risk Terminated

Nexterone

Reason Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged

Baxter Healthcare Corporation NDC 43066-150-10 D-0573-2018
Class I · High risk Terminated

GERICARE Eyewash

Reason Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans

Kareway Products Inc NDC 57896-0186-04 D-0551-2018
Class II · Moderate risk Terminated

Liothyronine Sodium Tablets

Reason Failed Dissolution Specifications.

Mayne Pharma Inc NDC 0574-0222-01 D-0098-2018
Class II · Moderate risk Terminated

Clozapine Tablets USP

Reason Failed Tablet/Capsule Specifications; potential presence of broken tablets.

Teva Pharmaceuticals USA NDC 00093-7772-05 D-0096-2018
Class II · Moderate risk Terminated

Maximum Strength Zephrex-D

Reason Microbial Contamination of Non-Sterile Products

L. Perrigo Company NDC 70085-151-01 D-0128-2018
Class III · Low risk Terminated

Ciprofloxacin in Dextrose

Reason Superpotent

Claris Lifesciences Inc NDC 36000-008-24 D-0127-2018
Class III · Low risk Terminated

Dexamethasone Sodium Phosphate Injection

Reason Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

West-Ward Pharmaceuticals Corp. NDC 0641-6146-01 D-0094-2018
Class III · Low risk Terminated

Dexamethasone Sodium Phosphate Injection

Reason Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

West-Ward Pharmaceuticals Corp. NDC 0641-6145-01 D-0093-2018
Class III · Low risk Terminated

bupPROPion HCL Extended-Release Tablets

Reason Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.

Mylan Pharmaceuticals Inc. D-0230-2018
Class II · Moderate risk Terminated

Extra Strength PreTAT by TAT BALM Gel

Reason GMP Deviations: inadequate manufacturing control processes

Ridge Properties, LLC NDC 69804-018-09 D-0087-2018
Class III · Low risk Terminated

Meclizine hydrochloride tablets USP

Reason Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-122-06 D-0082-2018
Class III · Low risk Terminated

Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol

Reason Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle

Dr. Reddy's Laboratories, Inc. D-0072-2018
Class I · High risk Terminated

Midazolam Injection

Reason Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Fresenius Kabi USA, LLC NDC 76045-001-20 D-0152-2018
Class II · Moderate risk Terminated

Estriol

Reason cGMP Deviations: lack of quality assurance at the API manufacturer.

Fagron, Inc NDC 51552-1392-5 D-0079-2018