FDA drug recalls

Asclemed USA Inc. is recalling Lidocaine HCl Injection USP 1% in 5 mL single-dose ampules due to lack of assurance of sterility. The affected lots were distributed nationwide. This is a precautionary measure to prevent potential infection risk from non-sterile product.

Asclemed USA Inc. is recalling specific lots of Accucaine, a lidocaine injection used for local anesthesia, because the manufacturer cannot guarantee the product is sterile. This affects multiple lot numbers distributed nationwide.

Boehringer Ingelheim Pharmaceuticals is recalling one lot of Synjardy XR 12.5/1000 mg tablets due to manufacturing quality control issues. During production, an incorrect cleaning agent was used on equipment, and required testing of that equipment was not completed before the tablets were made.

Accord Healthcare is recalling one lot of levothyroxine sodium 300 mcg tablets because they may contain less active ingredient than labeled. This means the medication may not work as intended for patients who need it to manage thyroid conditions.

Lupin Pharmaceuticals is recalling multiple lots of prednisolone acetate ophthalmic suspension 1% (an anti-inflammatory eye drop) due to the presence of a foreign substance in some bottles. The affected lots were distributed nationwide. No injuries have been reported.

Accord BioPharma is recalling one lot of IMULDOSA (ustekinumab-srlf) injection due to lack of assurance that the product is sterile. The affected lot may not meet sterility standards required for injectable medications. No injuries have been reported.

BD ChloraPrep CLear applicators intended for further processing and sterilization were distributed directly to customers without being sterilized first. The product is a skin antiseptic used before medical procedures. No injuries have been reported.

BD ChloraPrep CLear, a chlorhexidine-based skin antiseptic solution in single-use applicators, was distributed without proper sterilization. Unsterilized applicators intended for further processing were mistakenly sent to customers outside the intended distribution channel. This affects 18,000 units across multiple lot numbers distributed nationwide.

BD ChloraPrep Scrub Teal applicators intended for further processing and sterilization were mistakenly distributed as finished sterile products. The affected applicators may not meet sterility standards required for safe use in medical settings.

BD ChloraPrep Scrub Teal applicators intended for further processing and sterilization were distributed to customers without having been sterilized. The unsterilized applicators reached customers outside the intended distribution channel. About 1,200 units are affected.

BD ChloraPrep Hi-Lite Orange skin antiseptic applicators were distributed without proper sterilization. These units were intended for further processing and sterilization before use, but were instead sent directly to customers. This creates a risk of infection if the applicators are used as distributed.

BD ChloraPrep Hi-Lite Orange applicators intended for further sterilization before use were mistakenly distributed directly to customers without undergoing the required sterilization process. These applicators are used to prepare skin before medical procedures and must be sterile to be safe. The recall affects specific lot numbers distributed nationwide.

CareFusion distributed unsterilized ChloraPrep FREPP applicators (chlorhexidine gluconate and isopropyl alcohol solution) to customers outside their intended distribution channel. These applicators were meant for further processing and sterilization before use, but were shipped to end users without that sterilization step, creating a risk of infection if used on patients.

BD ChloraPrep Clear applicators (a skin-prep solution containing chlorhexidine and isopropyl alcohol) were distributed without proper sterilization. These applicators were intended to be sterilized before sale but were sent to customers in an unsterilized state. The affected products are in 3 ml applicator packs, with multiple lot numbers expiring between June 2026 and February 2029.

BD PurPrep sterile applicators (povidone-iodine with isopropyl alcohol) were distributed without proper sterilization assurance. Unsterilized applicators intended for further processing were shipped to customers outside the intended distribution channel, affecting Lot 4298581 (expires 09/30/2026).

BD ChloraPrep Hi-Lite Orange applicators (a skin antiseptic used before medical procedures) were distributed without proper sterilization. These applicators were intended to be sterilized before use, but some unsterilized units were sent to customers outside the normal supply chain.

Lupin Pharmaceuticals is recalling certain lots of its Glucagon Emergency Kit because the syringe plunger may not move smoothly during use. This defect was discovered during stability testing and could prevent the kit from working properly in an emergency.

Sun Pharmaceutical discovered that some bottles labeled as containing 6mg Perampanel tablets actually contained 10mg tablets instead. This mix-up affects one lot (AE01763) distributed nationwide. Patients taking the wrong strength could receive an incorrect dose of this seizure medication.

Elevate Oral Care's Povi-One 10% Povidone-Iodine Oral Antiseptic does not contain the full strength stated on the label. Five specific production lots distributed nationwide do not meet the required potency standard, which means the product may not work as intended for oral antiseptic purposes.

Some bottles of Lacosamide 100mg tablets may contain Selexipag 1000 mcg tablets instead. This mix-up happened during manufacturing and could cause patients to take the wrong medication. The recall affects specific lots distributed nationwide.

BD ChloraPrep FREPP Clear, a sterile skin antiseptic applicator, may contain fungal contamination (Aspergillus penicillioides) or may not be fully sterile due to wrinkles in the packaging seal. Approximately 178,000 applicators from lot 4073005 (expiring 03/31/2027) are affected nationwide and internationally.

BD ChloraPrep Clear, a sterile antiseptic skin-prep solution used before medical procedures, was found to contain Aspergillus penicillioides fungus in some applicators. This affects the sterility of the product, which is critical for medical use. The affected lot is Lot #4032183 with an expiration date of January 31, 2027.

BD ChloraPrep FREPP Clear applicators may have wrinkles in the paper lid that could compromise the sterile seal. This affects multiple lot numbers distributed nationwide through mid-2027. No injuries have been reported.

BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, is being recalled because wrinkles in the paper packaging lid may allow the sterile seal to be breached. This defect could potentially allow contamination of the product. No injuries have been reported.

PReye LLC is recalling all lots of PReye Vitamin See Antioxidant Preservative Free Eye Drops due to lack of assurance of sterility. The recall affects approximately 50 to 60 bottles distributed in Colorado. No injuries have been reported.

ANI Pharmaceuticals is recalling hydroxyzine hydrochloride oral solution (10 mg/5 mL, 473 mL bottles) due to the presence of a foreign substance in one lot. The affected product was distributed nationwide. No injuries have been reported.

Central Admixture Pharmacy Services issued a recall for one patient-specific Total Parenteral Nutrition (TPN) bag that did not contain copper and famotidine as listed on the label. The bag was prepared for a pediatric patient in Massachusetts. No injuries have been reported.

Direct Rx's packaged Duloxetine D/R 30 mg capsules contain levels of N-nitroso-duloxetine, a potentially harmful impurity, above FDA's recommended limit. This is a manufacturing quality issue affecting specific lots distributed nationwide.

Amgen is recalling Sensipar (cinacalcet) 90mg tablets due to deviations from current good manufacturing practice (CGMP) standards. This affects one lot distributed nationwide. No injuries have been reported.

Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets due to the presence of a foreign substance in some bottles. The affected lots were distributed nationwide. No injuries have been reported.