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© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 141–160 of 1,000 recalls

Class IIOngoing

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.

Harbin Jixianglong Biotech Co., Ltd.

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

February 13, 2026 · DrugView details →
Class IIOngoing

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

AvKARE

Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

February 13, 2026 · Drug
View details →
Class IIOngoing

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China

Harbin Jixianglong Biotech Co., Ltd.

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

February 13, 2026 · DrugView details →
Class IIOngoing

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,

LEO PHARMA INC

Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.

February 10, 2026 · DrugView details →
Class IIOngoing

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.

Meitheal Pharmaceuticals, Inc

Defective Delivery System: Missing or duplicated needles within the injection kit

February 9, 2026 · DrugView details →
Class IIOngoing

thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.

Fresenius Kabi Compounding, LLC

Lack of Assurance of Sterility

February 5, 2026 · DrugView details →
Class IIOngoing

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

Fresenius Kabi Compounding, LLC

Lack of Assurance of Sterility

February 5, 2026 · DrugView details →
Class IIOngoing

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Fresenius Kabi Compounding, LLC

Lack of Assurance of Sterility

February 5, 2026 · DrugView details →
Class IIOngoing

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

Fresenius Kabi Compounding, LLC

Lack of Assurance of Sterility

February 5, 2026 · DrugView details →
Class IIOngoing

acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56

Fresenius Kabi Compounding, LLC

Lack of Assurance of Sterility

February 5, 2026 · DrugView details →
Class IIOngoing

Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01

SOMERSET THERAPEUTICS LLC

Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.

February 4, 2026 · DrugView details →
Class IIOngoing

Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11

Pro Numb Tattoo Numbing Spray LLC

cGMP deviations

February 2, 2026 · DrugView details →
Class IIOngoing

Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11

Pro Numb Tattoo Numbing Spray LLC

cGMP deviations

February 2, 2026 · DrugView details →
Class IIOngoing

Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Teva Pharmaceuticals USA, Inc

Failed Dissolution Specifications

January 29, 2026 · DrugView details →
Class IIOngoing

Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Teva Pharmaceuticals USA, Inc

Failed Dissolution Specifications

January 29, 2026 · DrugView details →
Class IIOngoing

Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

Teva Pharmaceuticals USA, Inc

Failed Dissolution Specifications

January 29, 2026 · DrugView details →
Class IIOngoing

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

Teva Pharmaceuticals USA, Inc

Failed Dissolution Specifications

January 29, 2026 · DrugView details →
Class IIOngoing

Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

January 27, 2026 · DrugView details →
Class IIOngoing

Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)

Presence of Foreign substance - potential presence of metal particulate matter

January 26, 2026 · DrugView details →
Class IIOngoing

Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.

F.H. INVESTMENTS, Inc. (dba Asteria Health)

Presence of Foreign substance - potential presence of metal particulate matter

January 26, 2026 · DrugView details →
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