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 October 10, 2025
Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91
Failed Impurities/Degradation Specifications: not meeting quality requirements for impurity IP-C.
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-0142-2026
- Lot/product code:
- Lot #: 550172201, Exp. Date JAN-26; 550184801, Exp. Date MAR-26; 550204001, Exp. Date JUL-26
- Recalling firm:
- Endo USA, Inc.
Class IIILow risk
DrugRecalled October 10, 2025
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
Failed Impurities/Degradation Specifications: not meeting quality requirements for impurity IP-C.
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-0139-2026
- Lot/product code:
- Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
- Recalling firm:
- Endo USA, Inc.
Class IIILow risk
DrugRecalled October 10, 2025
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
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-0156-2026
- Lot/product code:
- Lot # 2405006633, Exp Date: 03/31/2026
- Recalling firm:
- Alembic Pharmaceuticals Limited
Class IIILow risk
DrugRecalled October 10, 2025
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
Failed Impurities/Degradation Specifications: not meeting quality requirements for impurity IP-C.
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-0141-2026
- Lot/product code:
- Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
- Recalling firm:
- Endo USA, Inc.
Class IIILow risk
DrugRecalled October 9, 2025
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
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-0025-2026
- Lot/product code:
- Lot: 25102464B, Expiry: 26NOV2025; 25102370A, Expiry: 20OCT2025; 25102369A, Expiry: 19OCT2025.
- Recalling firm:
- STAQ Pharma, Inc.
Class IIILow risk
DrugRecalled October 9, 2025
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
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-0023-2026
- Lot/product code:
- Lot #: 25104595A, Expiry: 27DEC2025.
- Recalling firm:
- STAQ Pharma, Inc.
Class IIILow risk
DrugRecalled October 9, 2025
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
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-0024-2026
- Lot/product code:
- Lot #: 25156673A, Expiry: 02FEB2026.
- Recalling firm:
- STAQ Pharma, Inc.
Class IIILow risk
FoodRecalled September 23, 2025
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.
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 #:
- H-0442-2026
- Lot/product code:
- OHB25230
- Recalling firm:
- Optiwize Inc.
Class IIILow risk
DrugRecalled September 12, 2025
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
Tablet/Capsules Imprinted with Wrong ID
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-0032-2026
- Lot/product code:
- Lot # PY925014A; Exp. 1/31/2028
- Recalling firm:
- JB Chemicals and Pharmaceuticals Ltd
Class IIILow risk
DrugRecalled September 12, 2025
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
Tablet/Capsules Imprinted with Wrong ID
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-0033-2026
- Lot/product code:
- Lot # PY925014, PY925013, Exp. 1/31/2028
- Recalling firm:
- JB Chemicals and Pharmaceuticals Ltd
Class IIILow risk
DrugRecalled September 5, 2025
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Failed Impurities/Degradation Specifications: not meeting quality requirements for impurity IP-C.
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-0026-2026
- Lot/product code:
- Lot #: 550172301, Exp. Date January 2026
- Recalling firm:
- Endo USA, Inc.
Class IIILow risk
DrugRecalled August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
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-0670-2025
- Lot/product code:
- lot#: GPC250159A, Exp Date: 06-22-2027
- Recalling firm:
- Granules Pharmaceuticals Inc.
Class IIILow risk
DrugRecalled August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
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-0673-2025
- Lot/product code:
- Lot#: GPC250181A, Exp Date: 06-19-2027
- Recalling firm:
- Granules Pharmaceuticals Inc.
Class IIILow risk
DrugRecalled August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
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-0672-2025
- Lot/product code:
- Lot#: GPC250179A, Exp Date: 06-22-2027
- Recalling firm:
- Granules Pharmaceuticals Inc.
Class IIILow risk
DrugRecalled August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
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-0671-2025
- Lot/product code:
- Lot#: GPC250178A, Exp Date: 06-22-2027
- Recalling firm:
- Granules Pharmaceuticals Inc.
Class IIILow risk
DrugRecalled August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
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-0669-2025
- Lot/product code:
- Lot#: GPC250158A, Exp Date: 06-22-2027
- Recalling firm:
- Granules Pharmaceuticals Inc.
Class IIILow risk
DrugRecalled August 25, 2025
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
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-0660-2025
- Lot/product code:
- Lot 0662036; Exp. Date 06/19/2027
- Recalling firm:
- Consumer Product Partners, LLC
Class IIILow risk
DrugRecalled August 25, 2025
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
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-0661-2025
- Lot/product code:
- Lot 0662036; Exp Date 06/19/2027
- Recalling firm:
- Consumer Product Partners, LLC
Class IIILow risk
DrugRecalled August 19, 2025
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
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-0674-2025
- Lot/product code:
- Lot # 24EJA180, Exp 06/01/2027
- Recalling firm:
- Medline Industries, LP
Class IIILow risk
DrugRecalled August 5, 2025
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
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-0592-2025
- Lot/product code:
- Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
- Recalling firm:
- Haleon US Holdings LLC
Class IIILow risk
DrugRecalled July 24, 2025
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Failed Stability Specifications: not meeting quality requirements results was observed in Induction Port during the analysis of Particle size distribution at the 12-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-0593-2025
- Lot/product code:
- Lot#: 4IB0519, Exp. 04/30/2026
- Recalling firm:
- Cipla USA, Inc.
Class IIILow risk
DrugRecalled July 9, 2025
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Weaker than it should be Drug: weaker than it should be assay results during stability testing.
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-0536-2025
- Lot/product code:
- Lot: 25MAR032, Exp. 07/16/2025.
- Recalling firm:
- Imprimis NJOF, LLC
Class IIILow risk
DrugRecalled July 9, 2025
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
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-0607-2025
- Lot/product code:
- 06092025@23 BUD 09/09/2025
- Recalling firm:
- Boothwyn Pharmacy LLC
Class IIILow risk
DrugRecalled June 26, 2025
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Failed Impurity/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-0528-2025
- Lot/product code:
- Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
- Recalling firm:
- AvKARE
Class IIILow risk
DrugRecalled June 26, 2025
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Failed Impurity/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-0529-2025
- Lot/product code:
- Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
- Recalling firm:
- AvKARE