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  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 801–820 of 18,048 recalls

Class IIOngoing

Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10

Teva Pharmaceuticals USA, Inc

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

October 7, 2025 · DrugView details →
Class IIOngoing

Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05

Teva Pharmaceuticals USA, Inc

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

October 7, 2025 · Drug
View details →
Class IIOngoing

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.

VIONA PHARMACEUTICALS INC

Discoloration

October 6, 2025 · DrugView details →
Class IIOngoing

Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), 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, 150 mg, 50 count bottle (NDC 23155-583-25), 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, 10 mg, 100 - count bottle (NDC 23155-578-01), 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, 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 →
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