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 North Carolina
Data last updated: September 6, 2026 at 11:49 PM UTC
17,100 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)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)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
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)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)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)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)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)UnclassifiedBacteria/virusAnnounced August 29, 2026
Martina — Mangoes
Potential contamination with Salmonella
Read FDA’s announcement (opens in a new tab)Class IIILow risk
DrugRecalled June 29, 2022
Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-405-60.
Failed Tablet/Capsule Specification : Capsule breakage
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1282-2022
- Lot/product code:
- Lot#: 17201639, Exp 08/2022; 17201759, Exp 09/2022; 17202067, Exp 10/2022; 17210696, Exp 02/2023; 17210092, Exp 11/2022; 17210145, Exp 12/2022; 17210732, Exp 02/2023; 17211062, Exp 04/2023; 17211441, Exp 05/2023; 17211670, Exp 06/2023; 17211810, Exp 07/2023; 17211862, 17212020, 17212068, Exp 08/2023; 17212438, Exp 10/2023; 17220172, 17220251, Exp 12/2023.
- Recalling firm:
- Glenmark Pharmaceuticals Inc., USA
Class IIILow risk
DrugRecalled July 11, 2022
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Defective Container: Tube split from side seam
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1304-2022
- Lot/product code:
- Lot #s: a) 15200058, 15200066, 15200067, Exp 06/2022; 15200075, Exp 07/2022; 15200094, Exp 08/2022; 15200119, 15200120, 15200122, Exp 09/2022; 15200131, 15200132, Exp 10/2022; 15200133, 15200134, 15200136, 15200139, Exp 11/2022; 15210033, 15210035, 15210036, 15210038 Exp 01/2023; 15210092, 15210094, 15210097, 15210099, Exp 03/2023; 15210100, 15210101, 15210104, Exp 04/2023; 15210122, Exp 05/2023; 15210148, 15210149, 15210153, 15210155, 15210157, 15210158, Exp 06/2023; 15210173, 15210174, 15210176, 15210177, 15210178, 15210179, Exp 07/2023; 15210184, 15210186, Exp 08/2023; 15210214, Exp 09/2023; 15210225, 15210226, 15210228, 15210230, 15210231, Exp 10/2023; 15220001, 15220002, Exp 12/2023. b) 15200092, Exp 08/2022; 15200114, 15200115, Exp 09/2022; 15200123, 15200124, Exp 10/2022; 15200142, 15200144, Exp 11/2022; 15210014, 15210015, 15210021, Exp 12/2022; 15210031, Exp 01/2023; 15210055, Exp 02/2023; 15210073, 15210075, Exp 03/2023; 15210117, 15210118, Exp 04/2023; 15210144, 15210147, 15210160, 15210162, Exp 06/2023; 15210171, Exp 07/2023; 15210187, 15210190, 15210191, 15210193, Exp 08/2023; 15210212, Exp 09/2023; 15210244, 15210247, Exp 11/2023; 15220007, Exp 12/2023; 15220019, 15220028, Exp 01/2024; 15220032, 15220034, 15220053, Exp 02/2024; 15220062, 15220064, 15220072, Exp 03/2024. c) 15200065, Exp 06/2022; 15200108, 15200109, Exp 09/2022; 15200125, Exp 10/2022; 15200148, 15200149, 15200150, Exp 11/2022; 15210007, 15210009, 15210012, 15210018, Exp 12/2022; 15210049, Exp 02/2023; 15210076, 15210077, 15210089, Exp 03/2023; 15210112, 15210114, Exp 04/2023; 15210124, 15210125, 15210127, Exp 05/2023; 15210169, 15210170, Exp 07/2023; 15210196, 15210199, Exp 08/2023; 15210204, 15210206, 15210207, 15210210, Exp 09/2023; 15210248, Exp 11/2023; 15220004, 15220013, 15220014, 15220015, Exp 12/2023; 15220025, 15220026, Exp 01/2024.
- Recalling firm:
- Glenmark Pharmaceuticals Inc., USA
Class IIILow risk
DrugRecalled August 8, 2022
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1471-2022
- Lot/product code:
- Lot #: 9N72, EXP 09/30/2022
- Recalling firm:
- Akorn, Inc
Class IIILow risk
DrugRecalled September 14, 2022
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Failed Stability Specifications: not meeting quality requirements results reported at 12-month stability testing for aluminum content.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0007-2023
- Lot/product code:
- Lot # ACB101, Exp 03/2023
- Recalling firm:
- Dr. Reddy's Laboratories, Inc.
Class IIILow risk
DrugRecalled September 26, 2022
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Presence of Particulate Matter: Piece of metal found in a vial
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1551-2022
- Lot/product code:
- Lot: CTA210006, Exp. 02/2024
- Recalling firm:
- AuroMedics Pharma LLC
Class IIILow risk
FoodRecalled January 13, 2023
Super Size Golden Harvest Carrot Cate, Item 06233. Net 9.8 kg 345 oz (21 lb 9 oz). UPC 7 70118-06233 6. Keep Frozen. Manufactured by: The Original Cakerie LTD, 1345 Cliveden Ave, Delta BC Canada V3M 6C7
Pieces of cashew and almond were found in box of walnuts which were used to make carrot cake.
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- F-0342-2023
- Lot/product code:
- Lot Code: 32921 Expiration Date: 25 November 2023
- Recalling firm:
- The Original Cakerie Ltd.
Class IIILow risk
DrugRecalled January 30, 2023
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Failed Stability Specifications: not meeting quality requirements test results for viscosity was identified at the 12M stability timepoint.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0265-2023
- Lot/product code:
- Lot: 081031A, Exp 2/28/2023
- Recalling firm:
- Akorn, Inc.
Class IIILow risk
DrugRecalled February 21, 2023
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0464-2023
- Lot/product code:
- Lot# SCDR, Exp 02/2024
- Recalling firm:
- Padagis US LLC
Class IIILow risk
DrugRecalled March 8, 2023
MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0532-2023
- Lot/product code:
- Lot W054586A, EXP 03/2026
- Recalling firm:
- Pfizer Inc.
Class IIILow risk
DrugRecalled March 16, 2023
Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13
Labeling; Incorrect NDC number on outer carton of product.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0535-2023
- Lot/product code:
- Lot numbers: 57943EMS, exp 5/31/2023; 56276EMS, exp 4/30/2024
- Recalling firm:
- Focus Health Group Inc
Class IIILow risk
FoodRecalled March 17, 2023
Duke's SOUTHERN SAUCES BAYOU REMOULADE NET WT. 10 FL OZ (296 ml) GLUTEN FREE INGREDIENTS:***SOY SAUCE (WHEAT, SOYBEANS, AND SALT)***CONTAINS SOY, WHEAT, EGGS SAUER BRANDS, INC. RICHMOND, VA 23220 UPC x 52500 08582 7
The firm was notified by a consumer that the product label is incorrect. The label says, "Gluten Free" however the product contains wheat.
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- F-0891-2023
- Lot/product code:
- BEST BY 09/08/23 22346M 19 09:43
- Recalling firm:
- Sauer Brands, Inc.
Class IIILow risk
DrugRecalled April 20, 2023
Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0556-2023
- Lot/product code:
- Lot: 204603, Exp: 09/30/2024; Lots:208608, 208749, 208445, 209101, 208609, 208295, 209106, 209102, 209212, 208975, 209211, 209706, 209779, 209624, 209839, 209548, Exp: 12/31/2024; Lots: 204604, 204601, 204550, 204599, 204871, 204555, 205616, Exp: 11/30/2024; Lots: 205612, 204832, 205127, 204996, 205615, 205324, 205494, 205611, 206232, Exp: 10/31/2024.
- Recalling firm:
- Bryant Ranch Prepack, Inc.
Class IIILow risk
DrugRecalled June 13, 2023
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Failed Impurities/Degradation Specifications: not meeting quality requirements results obtained for conductivity.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0875-2023
- Lot/product code:
- Lot: 44286 Exp. 02/2025
- Recalling firm:
- AVKARE LLC
Class IIILow risk
DrugRecalled June 23, 2023
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,
Failed Stability Specifications
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0896-2023
- Lot/product code:
- Lot #: 102101, Exp: 31 July 2024
- Recalling firm:
- Vivus, Inc.
Class IIILow risk
DrugRecalled July 27, 2023
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Failed Impurities/Degradation Specifications
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1086-2023
- Lot/product code:
- Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
- Recalling firm:
- ALEMBIC PHARMACEUTICALS, INC.
Class IIILow risk
DrugRecalled August 14, 2023
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Weaker than it should be: not meeting quality requirements for Assay Test at the 3-month time point.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1095-2023
- Lot/product code:
- Batch # 19224744
- Recalling firm:
- Glenmark Pharmaceuticals Inc., USA
Class IIILow risk
DrugRecalled August 14, 2023
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1103-2023
- Lot/product code:
- Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
- Recalling firm:
- Baxter Healthcare Corporation
Class IIILow risk
DrugRecalled August 16, 2023
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Failed dissolution specifications: below specification results at stability 12-month
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1143-2023
- Lot/product code:
- Lot# 1904872, Exp 1/31/2025; 1950377, Exp 6/30/2025
- Recalling firm:
- Esperion
Class IIILow risk
DrugRecalled August 17, 2023
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Cross contamination with other products
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-1142-2023
- Lot/product code:
- Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 .
- Recalling firm:
- Lundbeck LLC
Class IIILow risk
DrugRecalled October 17, 2023
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0088-2024
- Lot/product code:
- Lot # 1187435 exp date: 02/2024
- Recalling firm:
- AbbVie Inc.
Class IIILow risk
DrugRecalled October 20, 2023
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
Weaker than it should be Drug: Lower potency than labeled.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0094-2024
- Lot/product code:
- Lot 22W02, Exp 01/31/2025
- Recalling firm:
- Zyla Life Sciences US Inc.
Class IIILow risk
DrugRecalled November 10, 2023
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, KS 67226. NDC 71266-8240-01
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0125-2024
- Lot/product code:
- Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
- Recalling firm:
- Fagron Compounding Services
Class IIILow risk
DrugRecalled November 20, 2023
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66
Failed Dissolution Specifications
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0149-2024
- Lot/product code:
- Lot# ME2713; Exp. 02/2025 Lot # MF8286, ML1860; Exp. 04/2025
- Recalling firm:
- Siegfried Barbera, SL
Class IIILow risk
DrugRecalled December 26, 2023
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Stronger than it should be drug: Assay results were slightly above specification at the time zero point.
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0257-2024
- Lot/product code:
- Lot # 1014208, Exp Mar/31/2025
- Recalling firm:
- Amerisource Health Services LLC
Class IIILow risk
DrugRecalled January 18, 2024
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Misprint on tablet
ALL 50 STATES
▸Full report
A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.
- Recall #:
- D-0313-2024
- Lot/product code:
- Lot: T2303609; Exp. 06/2026 Lot: T2303610; Exp. 06/2026
- Recalling firm:
- Dr. Reddy's Laboratories, Inc.