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 Georgia
Data last updated: September 6, 2026 at 11:49 PM UTC
17,235 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, 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 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
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418
Incorrect Product Formulation
▸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-0740-2026
- Lot/product code:
- Lot #: 20-1535990-0-1 & 20-1535892-0-1, Exp. Date 16 July 2026
- Recalling firm:
- Central Admixture Pharmacy Services Inc
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
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 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 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 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 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 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 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