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FDA Drug Recalls

164 recalls · Class III, newest first

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-119-91 D-0142-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-128-91 D-0141-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-127-91 D-0140-2026

Class III · Low risk Ongoing Oct 10, 2025

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-125-91 D-0139-2026

Class III · Low risk Ongoing Oct 9, 2025

FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

STAQ Pharma, Inc. NDC 73177-0102-05 D-0025-2026

Class III · Low risk Ongoing Oct 9, 2025

Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

STAQ Pharma, Inc. NDC 73177-0156-02 D-0024-2026

Class III · Low risk Ongoing Oct 9, 2025

Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

STAQ Pharma, Inc. NDC 73177-0104-05 D-0023-2026

Class III · Low risk Ongoing Sep 12, 2025

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

Reason Labeling: Not Elsewhere Classified

Letco Medical LLC D-0138-2026

Class III · Low risk Ongoing Sep 12, 2025

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…

Reason Tablet/Capsules Imprinted with Wrong ID

JB Chemicals and Pharmaceuticals Ltd NDC 16571-402-50 D-0033-2026

Class III · Low risk Ongoing Sep 12, 2025

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…

Reason Tablet/Capsules Imprinted with Wrong ID

JB Chemicals and Pharmaceuticals Ltd NDC 16571-402-10 D-0032-2026

Class III · Low risk Ongoing Sep 5, 2025

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

Endo USA, Inc. NDC 49884-125-91 D-0026-2026

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-034-01 D-0673-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-032-01 D-0672-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-031-01 D-0671-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-030-01 D-0670-2025

Class III · Low risk Ongoing Aug 28, 2025

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate…

Reason Failed Impurities/Degradation Specifications:

Granules Pharmaceuticals Inc. NDC 70010-029-01 D-0669-2025

Class III · Low risk Ongoing Aug 25, 2025

TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC…

Reason Cross Contamination with Other Products.

Consumer Product Partners, LLC D-0661-2025

Class III · Low risk Ongoing Aug 25, 2025

Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC…

Reason Cross Contamination with Other Products.

Consumer Product Partners, LLC D-0660-2025

Class III · Low risk Ongoing Aug 19, 2025

READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA…

Reason Subpotent drug

Medline Industries, LP NDC 53329-939-25 D-0674-2025

Class III · Low risk Ongoing Aug 5, 2025

Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT…

Reason Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh…

Haleon US Holdings LLC D-0592-2025

Class III · Low risk Ongoing Jul 24, 2025

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore…

Reason Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the…

Cipla USA, Inc. NDC 69097-142-60 D-0593-2025

Class III · Low risk Ongoing Jul 9, 2025

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

Reason Subpotent Drug

Boothwyn Pharmacy LLC D-0607-2025

Class III · Low risk Ongoing Jun 26, 2025

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

Reason Failed Impurity/Degradation Specifications

AvKARE D-0529-2025

Class III · Low risk Ongoing Jun 26, 2025

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

Reason Failed Impurity/Degradation Specifications

AvKARE D-0528-2025

Class III · Low risk Ongoing Jun 16, 2025

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK…

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

Qualgen, LLC NDC 69761-202-01 D-0517-2025