UnclassifiedAnnounced September 4, 2026
Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement
Products contain undeclared yohimbine
Read FDA’s announcement (opens in a new tab)Recalls affecting Hawaii
Data last updated: September 6, 2026 at 11:49 PM UTC
16,136 recalls foundJust announced
Straight from FDA press releases — not yet formally classified or risk-gradedUnclassifiedBacteria/virusAnnounced September 4, 2026
Foods Alive — Moringa Leaf Powder
Potential to be contaminated with Salmonella
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced September 3, 2026
Great Value — Organic Triple Berry Blend
Possible E. Coli Contamination
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced September 3, 2026
B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Presence of particulate matter identified as iron oxide
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced September 3, 2026
American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Presence of particulate matter and lack of sterility assurance
Read FDA’s announcement (opens in a new tab)UnclassifiedAllergenAnnounced August 31, 2026
Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.
Undeclared milk
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced August 31, 2026
Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml
Contains garlic essential oil not approved for culinary use
Read FDA’s announcement (opens in a new tab)UnclassifiedAnnounced August 31, 2026
Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement
Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced August 29, 2026
Martina — Mangoes
Potential contamination with Salmonella
Read FDA’s announcement (opens in a new tab)UnclassifiedBacteria/virusAnnounced August 29, 2026
Everything Sprouts — Robust Radish Mix, 5oz Cups
Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.
Read FDA’s announcement (opens in a new tab)Class IHigh risk
DrugRecalled August 28, 2025
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0304-2026
- Lot/product code:
- LOT308EXP03/28
- Recalling firm:
- Green Lumber Holdings, LLC
Class IHigh risk
DrugRecalled August 27, 2025
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0655-2025
- Lot/product code:
- Lot No: GMML24026A, Expires: 09/30/2027
- Recalling firm:
- Unichem Pharmaceuticals USA Inc.
Class IHigh risk
DrugRecalled August 18, 2025
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Presence of Particulate Matter
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0627-2025
- Lot/product code:
- Lot #: J4S807, Exp 5/31/2027
- Recalling firm:
- B BRAUN MEDICAL INC
Class IHigh risk
DrugRecalled August 18, 2025
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Presence of Particulate Matter.
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0628-2025
- Lot/product code:
- Lot #: V3K770, Exp 1/31/2026
- Recalling firm:
- B BRAUN MEDICAL INC
Class IHigh risk
DrugRecalled July 30, 2025
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Microbial Contamination of Sterile Products: elevated endotoxin levels
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0094-2026
- Lot/product code:
- Lot#: GG121624-023, within expiry
- Recalling firm:
- GenoGenix LLC
Class IHigh risk
FoodRecalled July 25, 2025
Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.35OZ (10g) STRAWBERRY POUCHES 5-0.42OZ (12g) BANANA POUCHES 5-0.25 OZ (10g) APPLE POUCHES NET WT 5.6OZ (160g) NO ADDED SWEETENERS ONE INGREDIENT ONLY PER PACK UPC 1 93968 50900 2
Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- H-0394-2025
- Lot/product code:
- Best By: 06/24/2027 25175; Best By: 06/25/2027 25176; Best By: 06/26/2027 25177; Best By: 06/30/2027 25181; Best By: 07/01/2027 25182; Best By: 07/02/2027 25183; Best By: 07/03/2027 25184; Best By: 07/05/2027 25186; Best By: 07/07/2027 25188; Best By: 07/08/2027 25189; Best By: 07/09/2027 25190; Best By: 07/10/2027 25191; Best By: 07/11/2027 25192; Best By: 07/15/2027 25196; Best By: 07/16/2027 25197; Best By: 07/27/2027 25198; Best By: 07/18/2027 25199; Best By: 07/21/2027 25202; Best By: 07/22/2027 25203; Best By: 07/23/2027 25204; Best By: 07/24/2027 25205; Best By: 07/25/2027 25206
- Recalling firm:
- Doehler North America, Inc.
Class IHigh risk
DrugRecalled July 17, 2025
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0612-2025
- Lot/product code:
- Lot #: 30705A, Exp. Date 8/2025; 30771A, Exp. Date 9/2025; 30920A, Exp. Date 10/2025; 40016A, Exp. Date 1/2026; 40303A, Exp. Date 4/2026; 40428A, Exp. Date 5/2026; 40505A, Exp. Date 6/2026; 41053C, 41053A, 41053B, Exp. Date 12/2026, 50017A, Exp. Date 1/2027.
- Recalling firm:
- DermaRite Industries, LLC
Class IHigh risk
DrugRecalled July 17, 2025
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0611-2025
- Lot/product code:
- Lot #: 40187.2, Exp. Date 2/2026
- Recalling firm:
- DermaRite Industries, LLC
Class IHigh risk
DrugRecalled July 17, 2025
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0613-2025
- Lot/product code:
- Lot #: 31013A, Exp. Date 11/2025; 40345A, 40355A, Exp. Date 4/2026; 40571A, 40580A, Exp. Date 6/2026; 40587A, 40591A, Exp. Date 7/2026; 40870.1, 40877.1, Exp. Date 10/2026; 41093A, Exp. Date 12/2026; 50072A, 50079A, Exp. Date 1/2027
- Recalling firm:
- DermaRite Industries, LLC
Class IHigh risk
DrugRecalled July 17, 2025
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0610-2025
- Lot/product code:
- Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025; 30670A, 30682A, Exp. Date 8/2025; 40025A, Exp. Date 1/2026; 40375A, Exp. Date 4/2026; 40427A, 40436A, Exp. Date 5/2026; 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. Date 12/2025; 40012A, Exp. Date 1/2026; 40301A, Exp. Date 3/2026; 40789 A, Exp. Date 9/2026; 50068B, Exp. Date 1/2027; 50144A, 50149A, Exp. Date 2/2027.
- Recalling firm:
- DermaRite Industries, LLC
Class IHigh risk
DrugRecalled June 27, 2025
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0569-2025
- Lot/product code:
- Lot # PG4360, PG4362, Exp. 11/30/2027
- Recalling firm:
- Sandoz Inc
Class IHigh risk
DrugRecalled June 27, 2025
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0570-2025
- Lot/product code:
- Lot # PG4360, PG4362, Exp. 11/30/2027
- Recalling firm:
- Sandoz Inc
Class IHigh risk
DrugRecalled June 6, 2025
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0506-2025
- Lot/product code:
- All Lots.
- Recalling firm:
- Church & Dwight Inc
Class IHigh risk
DrugRecalled June 6, 2025
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0504-2025
- Lot/product code:
- All lots.
- Recalling firm:
- Church & Dwight Inc
Class IHigh risk
DrugRecalled June 6, 2025
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0505-2025
- Lot/product code:
- All Lots.
- Recalling firm:
- Church & Dwight Inc
Class IHigh risk
FoodRecalled June 4, 2025
Bornstein Frozen Shrimp Meat, Wild Caught - Product of USA. Product is cooked and Ready-To-Eat. Processed in the USA by Bornstein Seafoods Inc. Astoria, OR. The following items are being recalled: ZMU41-1003 Fzn Shrimp Meat 250/350 Ct 15 X 1lb. bag (net wt. 15lb) ZMU41-1007 Fzn Shrimp Meat 250/350 Ct 4 X 5lb. bag (net wt. 20lb) ZMU41-1015 Fzn Shrimp Meat 350/500 Ct 15 X 1lb. bag (net wt. 15lb) ZMU41-1019 Fzn Shrimp Meat 350/500 Ct 4 X 5lb bag (net wt. 20lb) ZMU41-1020 Fzn Shrimp Meat 350/500 Ct 20lb bag (net wt. 20lb) ZMU41-1045 Fzn Shrimp Meat 250/350 Ct 20lb bag (net wt. 20lb)
The recall was the result of the firm's routine sampling program and Listeria monocytogenes was detected in an in-process shrimp sample in a food production environment.
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- H-0069-2025
- Lot/product code:
- Item ZMU41-1003: Lot A19008 Item ZMU41-1007: Lot A18984, A19002, A19006, A19007, A19008, A19009, P11709, P11710, and P11714. Item ZMU41-1015: Lot A19009, A19019, A19026, A19030, A19032, A19037, and A19039. Item ZMU41-1019: Lot A18989, A19006, A19007, P11709, and P11710. Item ZMU41-1020: A19060 A19061 A19063 A19065 A19070 A19075 A19077 A19081 A19082 A19084 A19093 A19094 A19095 A19108 A19119 P11720 P11722 P11723 P11724 Item ZMU41-1045: A19030 A19032 A19033 A19037 A19039 A19060 A19063 A19064 A19065 A19068 A19069 A19070 A19075 A19076 A19082 A19084 A19094 A19108 P11709¿¿¿¿¿¿ P11722 P11724 P11730 Pl1723
- Recalling firm:
- Bornstein Seafoods Inc
Class IHigh risk
DrugRecalled June 2, 2025
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
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The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0488-2025
- Lot/product code:
- Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
- Recalling firm:
- Amneal Pharmaceuticals, LLC
Class IHigh risk
DrugRecalled May 21, 2025
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with not listed on the label ingredients: Dexamethasone and Diclofenac.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0493-2025
- Lot/product code:
- All Lots; All Expiration Dates.
- Recalling firm:
- Umary-USA.com
Class IHigh risk
DrugRecalled May 21, 2025
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with not listed on the label ingredients: Dexamethasone, Diclofenac and Omeprazole.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0492-2025
- Lot/product code:
- All Lots; All Expiration Dates.
- Recalling firm:
- Umary-USA.com
Class IHigh risk
DrugRecalled May 6, 2025
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0453-2025
- Lot/product code:
- Lot: 250214PRO, Expiration Date: 02/14/2027.
- Recalling firm:
- EnShiShiXiangNiShangMaoYouXianGongSi
Class IHigh risk
DrugRecalled April 17, 2025
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Presence of Particulate Matter
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0402-2025
- Lot/product code:
- Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
- Recalling firm:
- Amneal Pharmaceuticals, LLC
Class IHigh risk
DrugRecalled April 14, 2025
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label propoxyphenylsildenafil and sildenafil.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0466-2025
- Lot/product code:
- All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
- Recalling firm:
- SAINI TRADE INC
Class IHigh risk
DrugRecalled April 14, 2025
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label propoxyphenylsildenafil and sildenafil.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0467-2025
- Lot/product code:
- All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
- Recalling firm:
- SAINI TRADE INC
Class IHigh risk
DrugRecalled April 14, 2025
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label propoxyphenylsildenafil and sildenafil.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0464-2025
- Lot/product code:
- All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
- Recalling firm:
- SAINI TRADE INC
Class IHigh risk
DrugRecalled April 14, 2025
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with not listed on the label chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
ALL 50 STATES
▸Full report
The most serious kind of recall. Using this product could cause serious health problems or death.
- Recall #:
- D-0465-2025
- Lot/product code:
- All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
- Recalling firm:
- SAINI TRADE INC