
FDA•MODERATE
Octreotide Acetate for Injectable Suspension
Teva is recalling Octreotide Acetate 30 mg injection kits due to a lack of assurance of sterility.
2 products
Teva is recalling Octreotide Acetate 30 mg injection kits due to a lack of assurance of sterility.
2 products
Rising Pharma is recalling Enalapril Maleate 20 mg tablets (NDC 64980-688-10) due to failed impurities test.

CareFusion is recalling BD PurPrep sterile solution due to a lack of assurance of sterility and potential product contamination.
2 products
Fresenius recalls DELFLEX dialysis solution due to potential bag leaks compromising sterility.
2 products
Ajanta recalls Duloxetine 30 mg capsules over nitrosamine impurity above FDA limit.
3 products
Unichem is recalling 5 mg buspirone hydrochloride tablets due to subpotency, which may reduce the medication's effectiveness.

CVS is recalling Lidocaine Wound Gel (NDC 59898-950, 0.5 oz) due to failed pH specifications.

Hikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.

Scope Health is recalling Optase Dry Eye Intense Drops (0.33 fl oz, NDC 72972-002-01) due to lack of assurance of sterility.

Thea Pharma recalls iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) over sterility concerns from CGMP deviations.
2 products
American Regent is recalling Levocarnitine Injection, USP, 1 g/5 mL single-dose vials due to missing labels.

Wells Pharma recalls injectable drugs (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products
Alcon recalls Systane and GenTeal eye gels over sterility concerns.
2 products
Major Pharmaceuticals is recalling Omega-3-Acid Ethyl Esters Capsules due to failed stability testing for capsule shell loss on drying.

Premier Dental Products is recalling Monsel's Ferric Subsulfate Solution 8 mL vials (NDC 48783-112-08) due to incorrect expiration date on the vial label.

B. Braun recalls Sterile Water for Injection 3000 mL bags over sterility and leakage risk.
4 products
Harrow Eye LLC is recalling FreshKote Lubricant Eyedrops (0.33 fl oz) due to lack of assurance of sterility.

Skin Script Blemish Spot Treatment recalled over failed stability specifications; UPC 6 10563 13873 9.

Avantor is recalling Magnesium Chloride 6-Hydrate Crystal 500G bottles (NDC 10106-2448-1) due to subpotency.

Huvepharma is recalling one bag of Amprol 25% medicated article due to missing lot number and expiration date information.

Leading Pharma is recalling Furosemide Tablets 80 mg (NDC 69315-118-01) due to N-nitroso-Furosemide above recommended limits.

Teva is recalling Claravis 10 mg capsules (NDC 0555-1054-56, 0555-1054-86) due to out-of-specification Tretinoin impurity levels.
3 products
Major Pharmaceuticals is recalling 7 mg Memantine Hydrochloride Extended-Release Capsules due to failed dissolution specifications.

Camber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.

Apotex is recalling Desmopressin Nasal Spray (NDC 60505-0815-0) due to defective bottle caps with missing or dislodged liners.
3 products
International Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.

Teva recalls Clonidine Transdermal System 0.2 mg/day due to CGMP deviations (unapproved raw material).
3 products
Huons recalls injectable lidocaine, bupivacaine, and saline due to sterility concerns.
9 products
Island Kinetics recalls hydrocortisone 1% gels (Remedy Gel, Skin Rehab, Essential Calming) due to subpotency.
3 products
Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.

Taro recalls Fluocinonide 0.05% Cream 15g tubes due to out-of-spec viscosity.
3 products
Northwest Compounders is recalling Semaglutide-Glycine-Cyanocobalamin Injectable vials due to lack of assurance of sterility.

HydroPeptide Clear Alliance Serum recalled due to benzene contamination.
4 products
Cipla recalls Cinacalcet HCl 30 mg tablets over N-Nitroso impurity above acceptable limit.
3 products
Exchange Select Honey Lemon Cough Drops recalled over quality concerns from FDA inspection.
15 products
Cipla recalls Lanreotide Injection 120 mg/0.5 mL over sterility assurance concerns.
2 products
GE Healthcare recalls Omnipaque (iohexol) Injection 350 mg/mL due to particulate matter.
2 products
Viatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.

Teva is recalling 40 mg Isotretinoin Capsules due to potency issues.
2 products
Fagron recalls Vancomycin HCl 1.5g/250mL injection due to sterility concern.
5 products
Geri-Care Artificial Tears Lubricant Eye Drops (0.5 oz, NDC 68788-7266-0) recalled due to lack of sterility assurance.

Fresenius Kabi recalls 14 lots of Sodium Chloride and Dextrose Injections due to sterility concerns.
14 products
American Health Packaging is recalling Meclizine Hydrochloride 12.5 mg tablets (NDC 60687-775-65 and 60687-775-11) due to failed tablet specifications.

Appco Pharma recalls Prazosin HCl 1mg capsules over nitrosamine impurity (NNP) above acceptable limits.
3 products
K.C. Pharmaceuticals recalls multiple brands of sterile eye drops over sterility concerns.
15 products
Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.

Amneal is recalling 500-count bottles of Tramadol Hydrochloride 50 mg tablets due to an impurity found during stability testing.

Chiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.

Teva recalls Octreotide Acetate 20 mg vials over sterility assurance concerns.
6 products
MWI Animal Health is recalling Noromycin 300 LA oxytetracycline injection (NADA# 141-143) due to lack of assurance of sterility.
