Drug and pharmaceutical recalls
709 federal recalls in the last 12 months. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2026-07-19FDA-PRRelay Peak Research LLCZen Principle Moringa Capsules recalled for Salmonella risk
Zen Principle Moringa Capsules dietary supplement may be contaminated with Salmonella due to contamination in the moringa leaf powder ingredient. The affected product is Lot A6FF4 with a Best By date of 11/2028, distributed nationwide from December 2025 through July 2026 primarily online. No illnesses have been reported.
- 2026-07-18FDA-PRUnique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)Unique Pharmaceutical cetirizine tablets recalled for ranitidine contamination
Four lots of Unique Pharmaceutical Cetirizine Hydrochloride 5 mg tablets were found to be cross-contaminated with ranitidine. The contamination was discovered when pharmacy staff noticed red discoloration on some tablets. People with sensitivity to ranitidine could experience serious allergic reactions.
- 2026-07-08FDA-DrugCipla USA, Inc.Class IICipla Cinacalcet tablets recalled for N-nitroso impurity
Cipla USA is recalling Cinacalcet Hydrochloride 90 mg tablets (lot 5PB0563, expiring 4/30/2027) because they contain elevated levels of N-nitroso-cinacalcet, a potentially harmful impurity that exceeds acceptable daily intake limits. This is a manufacturing quality issue.
- 2026-07-08FDA-DrugCipla USA, Inc.Class IICipla Cinacalcet tablets recalled for N-nitroso impurity
Cipla USA is recalling certain batches of Cinacalcet Hydrochloride 60 mg tablets because they contain N-nitroso-cinacalcet, a chemical impurity, at levels above the FDA's acceptable daily intake. The affected lots were distributed nationwide. No injuries have been reported.
- 2026-07-08FDA-DrugCipla USA, Inc.Class IICipla Cinacalcet tablets recalled for impurity risk
Cipla USA is recalling specific lots of Cinacalcet Hydrochloride 30 mg tablets because they contain elevated levels of N-nitroso-cinacalcet, a manufacturing impurity that exceeds FDA safety limits. The affected bottles were distributed nationwide.
- 2026-07-08FDA-DrugLannett Company Inc.Class IILannett amphetamine capsules recalled for labeling mix-up
Lannett Company distributed amphetamine extended-release capsules that contained only immediate-release pellets but were labeled as extended-release. This labeling error could result in incorrect dosing and medication timing for patients who depend on the extended-release formulation.
- 2026-07-08FDA-DrugAsclemed USA Inc.Class IIAsclemed Lidocaine HCl Injection recalled for sterility concerns
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.
- 2026-07-08FDA-DrugAsclemed USA Inc.Class IIAccucaine lidocaine injection recalled for sterility concerns
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.
- 2026-07-08FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class IISynjardy XR tablets recalled for manufacturing deviation
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.
- 2026-07-08FDA-DrugACCORD HEALTHCARE, INC.Class IIAccord levothyroxine tablets recalled for subpotency
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.
- 2026-07-08FDA-DrugLupin Pharmaceuticals Inc.Class IILupin prednisolone acetate eye drops recalled for foreign substance
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.
- 2026-07-08FDA-DrugACCORD BIOPHARMA INCClass IIAccord BioPharma IMULDOSA injection recalled for sterility concerns
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep CLear recalled for sterility assurance issue
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep CLear recalled for unsterilized applicators
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Scrub Teal recalled for sterility concerns
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Scrub Teal recalled for sterility risk
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Hi-Lite Orange recalled for sterility assurance
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Hi-Lite Orange recalled for sterility concerns
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IICareFusion ChloraPrep applicators recalled for sterility concerns
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Clear recalled for sterility concerns
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.
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD PurPrep applicators recalled for sterility assurance issue
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).
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Hi-Lite Orange recalled for sterility issue
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.
- 2026-07-08FDA-DrugLupin Pharmaceuticals Inc.Not Yet ClassifiedLupin Glucagon Emergency Kit recalled for plunger defect
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.
- 2026-07-01FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IISun Pharmaceutical Perampanel recalled for tablet strength mix-up
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.
- 2026-07-01FDA-DrugElevate Oral CareClass IIElevate Oral Care Povi-One recalled for sub-potency
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.
- 2026-07-01FDA-DrugAnnora Pharma Private LimitedClass IICamber Lacosamide tablets recalled for Selexipag mix-up
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.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IBD ChloraPrep FREPP Clear recalled for sterility concerns
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.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IBD ChloraPrep Clear recalled for fungal contamination risk
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.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep FREPP Clear recalled for sterility risk
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.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Clear recalled for sterility assurance concern
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.
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