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
Chattem Inc
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanoo...
Oral Drugs·129,240 affected·Mar 26, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., M...
Oral Drugs·14,863 affected·Mar 26, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, ...
Oral Drugs·8,160 affected·Mar 11, 2025
High RiskFDA
Direct Rx
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berli...
Drugs·16 affected·Mar 7, 2025
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carto...
Oral Drugs·1,068 affected·Mar 7, 2025
High RiskFDA
Slate Run Pharmaceuticals
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piram...
Oral Drugs·2,444 affected·Mar 7, 2025
High RiskFDA
Mylan Institutional, Inc.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton...
Oral Drugs·347 affected·Mar 7, 2025
High RiskFDA
Slate Run Pharmaceuticals
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piram...
Oral Drugs·56,790 affected·Mar 7, 2025
High RiskFDA
Direct Rx
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-c...
Drugs·875 affected·Mar 7, 2025
High RiskFDA
Rising Pharma Holding, Inc.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663,...
Oral Drugs·1,223 affected·Mar 5, 2025
High RiskFDA
Chattem Inc
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured ...
Oral Drugs·180,696 affected·Mar 4, 2025
RecallFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major ...
Oral Drugs·224 affected·Mar 4, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharm...
Oral Drugs·18,696 affected·Feb 28, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Phar...
Oral Drugs·84,048 affected·Feb 28, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufa...
Oral Drugs·100 affected·Feb 28, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
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:...
Oral Drugs·100 affected·Feb 28, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barce...
Oral Drugs·11,125 affected·Feb 28, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc...
Oral Drugs·14,749 affected·Feb 28, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc...
Oral Drugs·11,100 affected·Feb 28, 2025
CriticalFDA
Central Admixture Pharmacy Services, Inc.
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 S...
Drugs·1,546 affected·Feb 20, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC...
Injectable Drugs·1,893 affected·Feb 13, 2025
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC...
Injectable Drugs·36,978 affected·Feb 13, 2025
High RiskFDA
Avkare
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals o...
Oral Drugs·1,266 affected·Feb 4, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·87,600 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·80,160 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·119,040 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: ...
Oral Drugs·58,368 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·70,032 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·133,824 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·56,208 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·58,416 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·175,920 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of Indi...
Oral Drugs·39,168 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·53,952 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India...
Oral Drugs·190,320 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·120,000 affected·Jan 29, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: G...
Oral Drugs·233,040 affected·Jan 29, 2025
High RiskFDA
Remedyrepack Inc.
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged...
Oral Drugs·247 affected·Jan 24, 2025
High RiskFDA
Sky Packaging
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distrib...
Oral Drugs·0 affected·Jan 24, 2025
High RiskFDA
Sky Packaging
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, Ind...
Oral Drugs·0 affected·Jan 24, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark P...
Oral Drugs·0 affected·Jan 22, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pha...
Oral Drugs·0 affected·Jan 22, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this pac...
Oral Drugs·82,281 affected·Jan 21, 2025
CriticalFDA
Provepharm Inc.
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Pro...
Injectable Drugs·24,640 affected·Jan 21, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa...
Oral Drugs·94,349 affected·Jan 21, 2025
High RiskFDA
Avkare
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Oral Drugs·341 affected·Jan 21, 2025
High RiskFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa...
Oral Drugs·27,525 affected·Jan 21, 2025
CriticalFDA
Getinge Usa Sales Inc
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For...
Medical Devices·6 affected·Jan 15, 2025