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
Ajanta Pharma Ltd.
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules...
Oral Drugs·312,894 affected·Apr 29, 2026
High RiskFDA
Ajanta Pharma Ltd.
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in Ind...
Oral Drugs·117,168 affected·Apr 29, 2026
High RiskFDA
Ajanta Pharma Ltd.
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in Ind...
Oral Drugs·77,376 affected·Apr 29, 2026
High RiskFDA
Jb Chemicals And Pharmaceuticals Ltd
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. C...
Injectable Drugs·675 affected·Apr 23, 2026
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelon...
Oral Drugs·165,761 affected·Apr 21, 2026
RecallFDA
Unichem Pharmaceuticals Usa Inc.
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road,...
Oral Drugs·10,875 affected·Apr 13, 2026
High RiskFDA
The Harvard Drug Group Llc
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distrib...
Oral Drugs·2,238 affected·Apr 9, 2026
High RiskFDA
Hikma Pharmaceuticals Usa Inc
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., ...
Oral Drugs·4 affected·Apr 7, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60...
Oral Drugs·5,101 affected·Apr 6, 2026
RecallFDA
Avantor Performance Materials Llc
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC,...
Drugs·36 affected·Mar 31, 2026
High RiskFDA
Appco Pharma Llc
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: ...
Oral Drugs·88,008 affected·Mar 27, 2026
High RiskFDA
Appco Pharma Llc
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by:...
Oral Drugs·58,896 affected·Mar 27, 2026
High RiskFDA
Appco Pharma Llc
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: ...
Oral Drugs·28,157 affected·Mar 27, 2026
High RiskFDA
Sun Pharmaceutical Industries Inc
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro P...
Topical Drugs·41,712 affected·Mar 25, 2026
High RiskFDA
Sun Pharmaceutical Industries Inc
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro P...
Topical Drugs·2,640 affected·Mar 25, 2026
High RiskFDA
Sun Pharmaceutical Industries Inc
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro P...
Topical Drugs·24,672 affected·Mar 25, 2026
High RiskFDA
Ge Healthcare Ireland Limited
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, N...
Injectable Drugs·306,810 affected·Mar 24, 2026
High RiskFDA
Ge Healthcare Ireland Limited
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, N...
Injectable Drugs·866,570 affected·Mar 24, 2026
High RiskFDA
Amneal Pharmaceuticals, Llc
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382...
Oral Drugs·29,542 affected·Mar 19, 2026
RecallFDA
Island Kinetics, Inc. D.b.a. Covalence Laboratories
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Topical Drugs·1,060 affected·Mar 18, 2026
RecallFDA
Island Kinetics, Inc. D.b.a. Covalence Laboratories
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75...
Topical Drugs·299 affected·Mar 18, 2026
RecallFDA
Island Kinetics, Inc. D.b.a. Covalence Laboratories
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW ...
Topical Drugs·2,895 affected·Mar 18, 2026
High RiskFDA
Rising Pharma Holding, Inc.
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allend...
Oral Drugs·1,200 affected·Mar 3, 2026
High RiskFDA
Macleods Pharma Usa, Inc
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manuf...
Oral Drugs·1,315 affected·Feb 26, 2026
High RiskFDA
Avkare
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.c...
Oral Drugs·0 affected·Feb 13, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Wrap Aprons.
Medical Devices·5,198 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Leg Wraps.
Medical Devices·103 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Half Aprons.
Medical Devices·402 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Vest
Medical Devices·15,438 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Demi Half Aprons.
Medical Devices·29 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Kilt Blockers.
Medical Devices·94 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Protective Sleeves.
Medical Devices·1,129 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Frontal Aprons
Medical Devices·14,323 affected·Feb 11, 2026
High RiskFDA
Burlington Medical, Llc
Burlington Medical, Blockers.
Medical Devices·51 affected·Feb 11, 2026
High RiskFDA
Somerset Therapeutics Llc
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somers...
Injectable Drugs·62,190 affected·Feb 4, 2026
High RiskFDA
Sun Pharmaceutical Industries Inc
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by ...
Topical Drugs·0 affected·Jan 27, 2026
High RiskFDA
Unichem Pharmaceuticals Usa Inc.
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS...
Oral Drugs·0 affected·Jan 21, 2026
High RiskFDA
Specialty Process Labs Llc
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, ...
Drugs·58 affected·Jan 16, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ ...
Oral Drugs·8,376 affected·Jan 12, 2026
High RiskFDA
Teva Pharmaceuticals Usa, Inc
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ ...
Oral Drugs·21,984 affected·Jan 12, 2026
High RiskFDA
Cipla Usa, Inc.
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA...
Injectable Drugs·15,221 affected·Jan 2, 2026
High RiskFDA
Avkare
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: ...
Oral Drugs·7,991 affected·Dec 31, 2025
RecallFDA
Sun Pharmaceutical Industries Inc
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10...
Topical Drugs·24,624 affected·Dec 30, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus...
Oral Drugs·22,896 affected·Dec 30, 2025
High RiskFDA
Novo Nordisk Inc.
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark,...
Injectable Drugs·0 affected·Dec 19, 2025
High RiskFDA
Novo Nordisk Inc.
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmar...
Injectable Drugs·0 affected·Dec 19, 2025
High RiskFDA
Imprimis Njof, Llc
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 W...
Injectable Drugs·314 affected·Dec 18, 2025
High RiskFDA
Imprimis Njof, Llc
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route ...
Injectable Drugs·596 affected·Dec 18, 2025