Civic Data
FDA RecallsUSDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

USDA Recalls

  • All USDA recalls
  • Poultry recalls
  • Meat recalls
  • Egg recalls

About

  • About us
  • FDA guides
  • USDA guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API
  • USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 381–400 of 1,000 recalls

Class IIOngoing

Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Heritage Pharmaceuticals Inc

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

October 6, 2025 · DrugView details →
Class IIOngoing

Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Heritage Pharmaceuticals Inc

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

October 6, 2025 · DrugView details →
Class IIOngoing

Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Heritage Pharmaceuticals Inc

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

October 6, 2025 · DrugView details →
Class IIOngoing

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

Advanced Pharmaceutical Technology, Inc.

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

October 3, 2025 · DrugView details →
Class IIOngoing

ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25

Church & Dwight Co., Inc.

Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.

October 1, 2025 · DrugView details →
Class IIOngoing

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).

Aspiro Pharma Limited

Presence of Particulate Matter: Particulate matter identified as glass

October 1, 2025 · DrugView details →
Class IIOngoing

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.

Acella Pharmaceuticals, LLC

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

September 29, 2025 · DrugView details →
Class IIOngoing

AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.

Acuity Specialty Products, Inc.

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

September 29, 2025 · DrugView details →
Class IIOngoing

Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.

Medline Industries, LP

Subpotent Drug

September 29, 2025 · DrugView details →
Class IIOngoing

Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.

Acuity Specialty Products, Inc.

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

September 29, 2025 · DrugView details →
Class IIOngoing

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25

Dr. Reddy's Laboratories, Inc.

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

September 26, 2025 · DrugView details →
Class IIOngoing

Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344

SV Labs Prescott Corporation

cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.

September 25, 2025 · DrugView details →
Class IIOngoing

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

Zydus Pharmaceuticals (USA) Inc

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

September 24, 2025 · DrugView details →
Class IIOngoing

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Zydus Pharmaceuticals (USA) Inc

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

September 24, 2025 · DrugView details →
Class IIOngoing

Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015

ACME UNITED CORPORATION

Product Mix-up

September 23, 2025 · DrugView details →
Class IIOngoing

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.

Park Avenue Compounding

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

September 23, 2025 · DrugView details →
Class IITerminated

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

RC Outsourcing, LLC

Lack of assurance of sterility.

September 22, 2025 · DrugView details →
Class IIOngoing

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054

Ascend Laboratories, LLC

Failed Dissolution Specifications

September 19, 2025 · DrugView details →
Class IIOngoing

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Ascend Laboratories, LLC

Failed Dissolution Specifications

September 19, 2025 · DrugView details →
Class IIOngoing

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Ascend Laboratories, LLC

Failed Dissolution Specifications

September 19, 2025 · DrugView details →
← PreviousPage 20 of 50Next →