FDA drug recalls

SpecGx LLC is recalling one lot of oxycodone and acetaminophen tablets (7.5 mg/325 mg) because some tablets may be missing the imprint (identifying mark). This makes it difficult to verify you have the correct medication. No injuries have been reported.

SpecGx LLC is recalling certain bottles of oxycodone and acetaminophen 10mg/325mg tablets because some tablets may be missing the imprint (marking). This could make it difficult to identify the medication. No injuries have been reported.

ORL Labs recalled ORL Kids Natural Toothpaste in Bubblegum Flavor due to deviations from manufacturing quality standards (cGMP). The affected product is Lot #250520P4 with expiration date 05/27, distributed in Arizona. No injuries have been reported.

ORL Kids Mouthwash in Bubblegum flavor did not meet FDA manufacturing standards during production. The issue affects 570 bottles distributed in Arizona with lot number 250505P9 and expiration date 05/27. No injuries have been reported.

Imprimis NJOF recalled Tri-Moxi+ eye injections because some batches contain glass-like particles. The affected batches (25JAN033A and 25JAN033B) expire in February 2026. No injuries have been reported.

Imprimis NJOF's dexamethasone-moxifloxacin-ketorolac eye injection contains glass-like particles that could contaminate the injection. This medication is used during eye surgery. The affected lots are 25APR001A and 25APR001B, expiring 04/03/2026.

Imprimis NJOF, LLC is recalling specific lots of Dexamethasone Moxifloxacin intraocular injection due to the presence of glass-like particles in the medication. This injection is used during eye surgery. Two affected lots have been identified and distributed nationwide.

Alembic Pharmaceuticals is recalling one lot of Fesoterodine Fumarate 8 mg extended-release tablets because testing found levels of a chemical impurity (diester impurity) that exceed safety limits. The affected lot is 2405003360, which expires January 31, 2026.

Zydus Pharmaceuticals is recalling certain bottles of trazodone 100mg tablets because some tablets have dents on the surface. The defect affects lot EA00237A with an expiration date of 04/30/2027. No injuries have been reported.

Glenmark Pharmaceuticals discovered that blister packs containing Ondansetron 4mg orally disintegrating tablets are not fully sealed, allowing tablets to fall out. The affected product was repackaged and distributed nationwide. This applies to lot #19251311 with an expiration date of April 2027.

Novo Nordisk has recalled specific batches of Wegovy (semaglutide) 1 mg injection pens because hair was found inside prefilled syringes. This affects two lot numbers distributed nationwide. No injuries have been reported.

Novo Nordisk discovered hair in some prefilled Wegovy injection pens. This affects specific lot numbers manufactured in Denmark. No injuries have been reported.

CareFusion 213, LLC is recalling BD ChloraPrep Triple Swabsticks (a skin antiseptic swab) because the manufacturer cannot confirm the product was properly sterilized. The affected lot (#5086623, expiring 3/31/2028) was distributed nationwide. No injuries have been reported.

Merck has recalled specific lots of Noxafil Powdermix, a prescription antifungal medication, because some packets may contain metal particles. This affects 845 kits distributed nationwide. No injuries have been reported.

Merck has recalled a limited lot of Emend (aprepitant) 125 mg oral suspension due to the potential presence of metal particles in the product. This affects 3 single-dose kits with lot number Z014503 and expiration date 11/15/2027 distributed nationwide.

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.