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 South Carolina
Data last updated: September 6, 2026 at 11:49 PM UTC
16,707 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 July 16, 2026
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
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-0737-2026
- Lot/product code:
- Lot: 25141583, Exp. April 30, 2027.
- Recalling firm:
- Ascend Laboratories, LLC
Class IIILow risk
DrugRecalled July 16, 2026
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
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-0739-2026
- Lot/product code:
- Lot: 25141586, Exp. April 30, 2027.
- Recalling firm:
- Ascend Laboratories, LLC
Class IIILow risk
DrugRecalled July 16, 2026
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
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-0738-2026
- Lot/product code:
- Lot: 25141585, Exp. April 30, 2027.
- Recalling firm:
- Ascend Laboratories, LLC
Class IIILow risk
DrugRecalled July 6, 2026
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.
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-0758-2026
- Lot/product code:
- Lot # 2075801, Exp Date: 31-Oct-2029.
- Recalling firm:
- Supernus Pharmaceuticals, Inc.
Class IIILow risk
DrugRecalled June 30, 2026
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
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-0736-2026
- Lot/product code:
- Lot: 25141584, Exp 4/30/2027.
- Recalling firm:
- Ascend Laboratories, LLC
Class IIILow risk
DrugRecalled June 30, 2026
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
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-0735-2026
- Lot/product code:
- Lot: 25141707, Exp 4/30/2027.
- Recalling firm:
- Ascend Laboratories, LLC
Class IIILow risk
DrugRecalled June 3, 2026
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
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-0585-2026
- Lot/product code:
- Lot AM251676, EXP 11/31/2028
- Recalling firm:
- Amneal Pharmaceuticals, LLC
Class IIILow risk
DrugRecalled June 2, 2026
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Presence of foreign substance
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-0619-2026
- Lot/product code:
- Lot S25133A
- Recalling firm:
- ANI Pharmaceuticals, Inc.
Class IIILow risk
DrugRecalled June 1, 2026
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Labeling: Incorrect or Missing Lot and/or Exp Date
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-0608-2026
- Lot/product code:
- Lot VA0099422; Exp. Date June 30, 2028
- Recalling firm:
- Sandoz Inc
Class IIILow risk
DrugRecalled June 1, 2026
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
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-0654-2026
- Lot/product code:
- Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
- Recalling firm:
- SUN PHARMACEUTICAL INDUSTRIES INC
Class IIILow risk
DrugRecalled May 18, 2026
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
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-0552-2026
- Lot/product code:
- Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029
- Recalling firm:
- Eugia US LLC
Class IIILow risk
DrugRecalled May 18, 2026
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
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-0551-2026
- Lot/product code:
- Lot # 402805, 407596, Exp Date: 08/2026.
- Recalling firm:
- AbbVie Inc.
Class IIILow risk
DrugRecalled May 14, 2026
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
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-0550-2026
- Lot/product code:
- Lot #: 56841, Expires: 03/2028
- Recalling firm:
- AVEVA Drug Delivery Systems, Inc.
Class IIILow risk
DrugRecalled May 14, 2026
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Failed Impurities/Degradations 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-0581-2026
- Lot/product code:
- Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
- Recalling firm:
- Fresenius Kabi USA, LLC
Class IIILow risk
DrugRecalled May 4, 2026
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
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-0539-2026
- Lot/product code:
- Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
- Recalling firm:
- Sagent Pharmaceuticals
Class IIILow risk
DrugRecalled May 1, 2026
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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-0536-2026
- Lot/product code:
- Lot#: 1027583, Exp 09/30/2027
- Recalling firm:
- Amerisource Health Services LLC
Class IIILow risk
DrugRecalled May 1, 2026
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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-0537-2026
- Lot/product code:
- Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- Recalling firm:
- Amerisource Health Services LLC
Class IIILow risk
DrugRecalled April 27, 2026
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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-0534-2026
- Lot/product code:
- Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028
- Recalling firm:
- Golden State Medical Supply Inc.
Class IIILow risk
DrugRecalled April 27, 2026
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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-0535-2026
- Lot/product code:
- Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
- Recalling firm:
- Golden State Medical Supply Inc.
Class IIILow risk
DrugRecalled April 24, 2026
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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-0533-2026
- Lot/product code:
- Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
- Recalling firm:
- Lannett Company Inc.
Class IIILow risk
DrugRecalled April 16, 2026
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Labeling: Missing Label
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-0494-2026
- Lot/product code:
- Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
- Recalling firm:
- American Regent, Inc.
Class IIILow risk
DrugRecalled April 14, 2026
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
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-0490-2026
- Lot/product code:
- Lot #: 640911253, Exp Date. 09/14/2027.
- Recalling firm:
- Premier Dental Products Co
Class IIILow risk
DrugRecalled April 13, 2026
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Weaker than it should be drug
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-0511-2026
- Lot/product code:
- Lot: ZBUL25001, Exp 12/31/2027
- Recalling firm:
- Unichem Pharmaceuticals USA Inc.
Class IIILow risk
DrugRecalled April 7, 2026
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
Failed PH 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-0509-2026
- Lot/product code:
- Lots: A5014, A5018, A5019
- Recalling firm:
- Water-Jel Technologies, LLC
Class IIILow risk
DrugRecalled March 31, 2026
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
Weaker than it should be drug
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-0488-2026
- Lot/product code:
- Lot 23G3161005, Exp 9/21/2027
- Recalling firm:
- Avantor Performance Materials LLC