Drug and pharmaceutical recalls

Taro Pharmaceuticals is recalling specific lots of Ciclopirox Shampoo 1% because the product failed quality tests for impurities and degradation at the 18-month mark. The affected lots expire January 31, 2026. No injuries have been reported.

Preferred Pharmaceuticals is recalling ondansetron ODT 4mg tablets because the blister pack containers are not fully sealed, which can cause tablets to fall out. The manufacturer Glenmark Pharmaceuticals notified Preferred Pharmaceuticals of the sealing defect. This affects specific lot numbers distributed nationwide.

Somerset Therapeutics is recalling cisatracurium besylate injection (a muscle relaxant used during surgery) because stability testing found the drug strength fell below the required standard. Lot A250043 with expiration date 06/30/2026 is affected. The company has not reported any injuries.

Somerset Therapeutics is recalling cisatracurium besylate injection (200mg/20mL vials, Lot #A250020, expiration 06/30/2026) because stability testing found the drug's strength fell below required standards. This means the medication may not work as intended during medical procedures.

Somerset Therapeutics is recalling specific lots of cisatracurium besylate injection because testing found the drug contains less active ingredient than labeled. The affected vials may not work as intended during medical procedures. No injuries have been reported.

Golden State Medical Supply's baclofen 10 mg tablets in 1,000-count bottles (Lot GS065762) may contain foreign tablets or capsules mixed in. This affects 2,472 bottles distributed nationwide. No injuries have been reported.

OraVerse (phentolamine mesylate) injection cartridges in one lot have been found with cracks or breaks in the container. Affected cartons contain 10 cartridges each and were distributed nationwide. No injuries have been reported.

Novocol Pharmaceutical is recalling one lot of Carbocaine 3% mepivacaine injection because some cartridges in affected cartons are cracked or broken. Cracked containers can allow contamination or leakage of the medication. No injuries have been reported.

Benco Dental is recalling Mepivacaine HCI 3% injection cartridges (lot D05159H, expires 07-31-2027) because some cartridges may be cracked or broken. A defective container could allow the medication to leak or become contaminated. No injuries have been reported.

Novocol Pharmaceutical's Mepivacaine HCI 3% injection cartridges may have cracked or broken containers. This defect affects one lot (D05159G) distributed nationwide. The cracked cartridges could compromise the integrity of the medication.

Novocol Polocaine 3% dental anesthetic cartridges in one specific lot may have cracked or broken containers. This defect could compromise the sterility and safety of the medication. No injuries have been reported.

Novocol Pharmaceutical's lidocaine HCI 2% and epinephrine injection cartridges (50-count boxes) may have cracks or breaks in the containers. This defect could affect the sterility and safety of the medication. The affected lot D05362A expires July 31, 2027.

Novocol Pharmaceutical issued a recall of 2% Xylocaine Dental with Epinephrine 1:100,000 injection cartridges due to defective containers—some cartridges are cracked or broken. This affects lot D05337B (expires 06-30-2027). The problem was discovered during quality control; no injuries have been reported.

Defective container - seal not adhering to bottles

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Cross Contamination with Other Products

Incorrect Product Formulation

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Failed stability specifications: Out of specification for hardness test

Failed stability specifications: Out of specification for hardness test

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

cGMP deviations

cGMP deviations

cGMP deviations