Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

11001–11025 of 18028

LowFDA (Drugs)·D-0607-2017·2017-03-29
Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure
Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.
Product
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0528-2017·2017-03-22
Synergy Rx Recalls Minoxidil Products Due to Sterility Assurance Concerns
Synergy Rx is recalling Minoxidil and Minoxidil/Retinoic Acid products nationwide due to a lack of assurance of sterility and CGMP deviations.
Product
MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0602-2017·2017-03-22
Synergy Rx Recalls Kojic Acid and Azelaic Acid Cream Due to Sterility Concerns
Synergy Rx is recalling Kojic Acid 8%/Azelaic Acid 15% Cream because it lacks assurance of sterility and has CGMP deviations.
Product
KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0574-2017·2017-03-22
Synergy Rx Recalls Tri-Bleaching Cream Due to Sterility Assurance Issues
Synergy Rx is recalling Tri-Bleaching Cream because it lacks assurance of sterility and has CGMP deviations.
Product
TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0533-2017·2017-03-22
Synergy Rx Bleaching Cream Recalled for Sterility Assurance Issues
Synergy Rx is recalling Bleaching Cream products due to a lack of assurance of sterility and CGMP deviations.
Product
BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0593-2017·2017-03-22
Synergy Rx Recalls Lidocaine Creams Due to Sterility Assurance Issues
Synergy Rx is recalling various lidocaine cream and ointment products nationwide due to a lack of assurance of sterility and CGMP deviations.
Product
LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0594-2017·2017-03-22
Synergy Rx Recalls Azelaic Acid 15% Cream Due to Sterility Concerns
Synergy Rx is recalling Azelaic Acid 15% Cream because the product lacks assurance of sterility and has CGMP deviations.
Product
AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0552-2017·2017-03-22
Synergy Rx Recalls Calming Cream Due to Sterility Assurance Concerns
Synergy Rx is recalling Calming Cream (Hydrocortisone 2.5%) because the product lacks assurance of sterility and has CGMP deviations.
Product
CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0555-2017·2017-03-22
Synergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns
Synergy Rx is recalling all lots of CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2%) because the product lacks assurance of sterility and has CGMP deviations.
Product
CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0581-2017·2017-03-22
Synergy Rx Recalls Betamethasone 0.25% Due to Sterility Assurance Issues
Synergy Rx is recalling Betamethasone 0.25% cream because it may not be sterile. The recall covers all lots distributed nationwide.
Product
BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0536-2017·2017-03-22
Synergy Rx Recalls Erythromycin Cream Due to Sterility Assurance Issues
Synergy Rx is recalling Erythromycin 2% in CeraVe Cream and Erythromycin 3% / Retinoic Acid 0.05% due to lack of assurance of sterility and CGMP deviations.
Product
ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0567-2017·2017-03-22
Synergy Rx Recalls Quad Bleaching Cream Due to Sterility Concerns
Synergy Rx is recalling Quad Bleaching Cream because it lacks assurance of sterility and has CGMP deviations.
Product
QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0584-2017·2017-03-22
Synergy Rx Recalls HCG Products Due to Sterility Assurance Issues
Synergy Rx is recalling all lots of HCG products nationwide due to a lack of assurance of sterility and CGMP deviations.
Product
HCG in all strength including: 2,400, 9600,12,000 UNIT POWDER VIAL DROPS, HCG 11,000/B-12 UNITS SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0524-2017·2017-03-22
Synergy Rx Recalls HCG Tablets Due to Sterility Assurance Concerns
Synergy Rx is recalling HCG and HCG with resveratrol tablets nationwide due to a lack of assurance of sterility and CGMP deviations.
Product
HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL 50MG S.L. Tablet, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0568-2017·2017-03-22
Synergy Rx Recalls QUAD PEEL Due to Sterility Assurance Concerns
Synergy Rx is recalling QUAD PEEL chemical peels nationwide due to a lack of assurance of sterility and CGMP deviations.
Product
QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0530-2017·2017-03-22
Synergy Rx Recalls Topical Gels and Creams Due to Sterility Concerns
Synergy Rx is recalling specific prescription topical gels and creams because they may lack assurance of sterility and have CGMP deviations.
Product
ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM, AZELAIC ACID 20% IN OI FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0600-2017·2017-03-22
Synergy Rx Recalls Gentle Supreme Bleaching Cream Due to Sterility Concerns
Synergy Rx is recalling Gentle Supreme Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.
Product
GENTLE SUPREME BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0599-2017·2017-03-22
Synergy Rx Custom Lightening Cream Recalled for Sterility Assurance Issues
Synergy Rx is recalling Custom Lightening/Brightening Cream due to lack of assurance of sterility and CGMP deviations.
Product
CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0569-2017·2017-03-22
Synergy Rx Recalls Rosacea Cream Due to Sterility Assurance Concerns
Synergy Rx is recalling Rosacea Cream because the product lacks assurance of sterility and has CGMP deviations.
Product
ROSACEA CREAM ( Metronidazole 1%, Niacinamide 4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0597-2017·2017-03-22
Synergy Rx Recalls Sulfacetamide and Hydrocortisone Cream for Sterility Concerns
Synergy Rx is recalling Sulfacetamide 10%/Hydrocortisone 1% Cream due to lack of assurance of sterility and CGMP deviations.
Product
SULFACETAMIDE 10%/HYDROCORTISONE 1% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0583-2017·2017-03-22
Synergy Rx Enhanced Retin Cream Recalled for Sterility Assurance Issues
Synergy Rx is recalling Enhanced Retin Anti-Wrinkle Cream products due to a lack of assurance of sterility and CGMP deviations.
Product
ENHANCED RETIN ANTI-WRINKLE CREAM, ENHANCED RETIN ANTI-WRINKLE CREAM 0.1%, ENHANCED RETIN 0.025% and 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0540-2017·2017-03-22
Synergy Rx Recalls Glycolic Acid Solution Due to Sterility Concerns
Synergy Rx is recalling all strengths of Glycolic Acid Solution because the product lacks assurance of sterility and has CGMP deviations.
Product
GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0523-2017·2017-03-22
Synergy Rx Recalls Cantharidin and Podophyllum Solutions Due to Sterility Concerns
Synergy Rx is recalling Cantharidin 0.7% Solution and Cantharidan/Podophyllum Solution due to lack of assurance of sterility and CGMP deviations.
Product
CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0518-2017·2017-03-22
Isomeric Pharmacy Recalls Triamcinolone Injection Vials Due to CGMP Deviations
Isomeric Pharmacy Solution is recalling 6,999 vials of Triamcinolone 40 mg/mL injection due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0572-2017·2017-03-22
Synergy Rx Supreme Cream Recalled for Sterility Assurance Issues
Synergy Rx is recalling Supreme Cream due to a lack of assurance of sterility and CGMP deviations.
Product
SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Category
Drug
Distribution
Distributed nationwide

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11001–11025 of 18028