Hazard Type

Product Quality Recalls

2,865 product recalls involving product quality. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

2,865Total Recalls
260Critical
322.2MUnits Affected
All Recalls

Every Product Quality Recall

Sorted by most recent. Click any recall for full details and safety information.

2,865 recalls
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses ...
Oral Drugs·6,408 affected·Jan 13, 2025
RecallFDA
Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc....
Oral Drugs·4,080 affected·Jan 7, 2025
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Dist...
Oral Drugs·42,527 affected·Dec 30, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Ph...
Oral Drugs·244,460 affected·Dec 30, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ...
Oral Drugs·73,680 affected·Dec 30, 2024
High RiskFDA
Eugia Us Llc
Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ ...
Injectable Drugs·17,300 affected·Dec 27, 2024
High RiskFDA
Viatris Inc
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 2650...
Oral Drugs·1,215 affected·Dec 23, 2024
High RiskFDA
Viatris Inc
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 265...
Oral Drugs·6,605 affected·Dec 23, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Ma...
Oral Drugs·480 affected·Dec 20, 2024
High RiskFDA
Granules Pharmaceuticals Inc.
Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03
Oral Drugs·96 affected·Dec 18, 2024
RecallFDA
Somerset Therapeutics Llc
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, ND...
Ophthalmic Drugs·5,870 affected·Dec 16, 2024
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend ...
Oral Drugs·10,444 affected·Dec 12, 2024
High RiskFDA
Ascend Laboratories, Llc
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend ...
Oral Drugs·1,971 affected·Dec 12, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product ...
Oral Drugs·3,888 affected·Dec 11, 2024
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product...
Oral Drugs·0 affected·Dec 11, 2024
High RiskFDA
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Ma...
Oral Drugs·163,883 affected·Dec 6, 2024
High RiskFDA
Amerisource Health Services Llc
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090,...
Oral Drugs·13,678 affected·Dec 6, 2024
High RiskFDA
Amerisource Health Services Llc
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, ...
Oral Drugs·21,262 affected·Dec 6, 2024
High RiskFDA
Amerisource Health Services Llc
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, ...
Oral Drugs·20,734 affected·Dec 6, 2024
High RiskFDA
Aurobindo Pharma Usa Inc
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Wi...
Oral Drugs·0 affected·Dec 6, 2024
High RiskFDA
Breckenridge Pharmaceutical, Inc
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. M...
Oral Drugs·76,968 affected·Dec 6, 2024
High RiskFDA
Amerisource Health Services Llc
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 0...
Oral Drugs·1,815 affected·Dec 6, 2024
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Drugs·70 affected·Dec 4, 2024
High RiskFDA
Remedyrepack Inc.
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx on...
Oral Drugs·1,564 affected·Dec 2, 2024
High RiskFDA
Avkare
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Oral Drugs·2,396 affected·Nov 27, 2024
High RiskFDA
Avkare
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Oral Drugs·2,796 affected·Nov 27, 2024
High RiskFDA
Avkare
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Oral Drugs·50,304 affected·Nov 27, 2024
High RiskFDA
Macleods Pharmaceuticals Ltd
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured f...
Oral Drugs·15,744 affected·Nov 25, 2024
RecallFDA
Dr. Reddy's Laboratories, Inc.
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, N...
Oral Drugs·7,233 affected·Nov 22, 2024
High RiskFDA
Apothecus Pharmaceutical Corp.
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmac...
Topical Drugs·33,659 affected·Nov 22, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·1,664 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·205 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man...
Oral Drugs·2,835 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·690 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·988 affected·Nov 19, 2024
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, M...
Oral Drugs·1,133 affected·Nov 19, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottl...
Oral Drugs·233,003 affected·Nov 19, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 572...
Oral Drugs·122,925 affected·Nov 19, 2024
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, ...
Oral Drugs·209,376 affected·Nov 19, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10...
Oral Drugs·9,828 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10...
Oral Drugs·65,169 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10)...
Oral Drugs·42,331 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10...
Oral Drugs·92,512 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10...
Oral Drugs·55,032 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10...
Oral Drugs·35,883 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10...
Oral Drugs·19 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10...
Oral Drugs·118,324 affected·Nov 18, 2024
High RiskFDA
Viatris Inc
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10)...
Oral Drugs·43,765 affected·Nov 18, 2024