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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

OOS results reported for the Dissolution (by UV) test.

May 15, 2025 Prescription Drugs Nationwide View Details →

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Feb 28, 2025 Prescription Drugs Nationwide View Details →

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Feb 28, 2025 Prescription Drugs Nationwide View Details →

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

Alembic Pharmaceuticals Limited

Class I - Dangerous

Failed Impurities/Degradation Specifications

May 7, 2025 Prescription Drugs Nationwide View Details →

ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N

EnShiShiXiangNiShangMaoYouXianGongSi

Class I - Dangerous

Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).

May 6, 2025 Prescription Drugs Nationwide View Details →

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .

AsttraZeneca Pharmaceuticals

Class I - Dangerous

Defective delivery system

May 14, 2025 Prescription Drugs Nationwide View Details →

Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

May 13, 2025 Prescription Drugs Nationwide View Details →

Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Over-the-Counter View Details →

Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.

KVK Tech

Class I - Dangerous

cGMP deviations

May 9, 2025 Prescription Drugs Nationwide View Details →

Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03

KENIL HEALTHCARE PRIVATE LIMITED

Class I - Dangerous

CGMP Deviations

Apr 24, 2025 Other Drugs View Details →

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

May 13, 2025 Prescription Drugs Nationwide View Details →