Drug and pharmaceutical recalls
17658 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2026-06-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IISun Pharmaceutical budesonide recalled for foreign particles
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
- 2026-06-17FDA-DrugAscend Laboratories, LLCClass IIAscend Minocycline tablets recalled for dissolution failure
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- 2026-06-17FDA-DrugHaleon US Holdings LLCClass IGas-X Extra Strength recalled for coolant contamination
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- 2026-06-17FDA-DrugGolden State Medical Supply Inc.Class IIGolden State Medical Supply niacin tablets recalled for dissolution failure
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
- 2026-06-17FDA-DrugZep IncClass IIZep Alcohol Sanitizer Spray recalled for microbial contamination
Microbial contamination of sterile products
- 2026-06-17FDA-DrugAmneal Pharmaceuticals, LLCClass IIIAmneal Primidone tablets recalled for cross-contamination risk
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- 2026-06-17FDA-DrugBreckenridge Pharmaceutical, Inc.Class IIBreckenridge Duloxetine 60mg recalled for impurity risk
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2026-06-17FDA-DrugBreckenridge Pharmaceutical, Inc.Class IIBreckenridge Duloxetine capsules recalled for impurity concern
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2026-06-17FDA-DrugFresenius Kabi USA, LLCClass IIIFresenius Kabi epinephrine injection recalled for impurity concerns
Failed Impurities/Degradations Specifications
- 2026-06-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass ISun Pharmaceutical doxorubicin injection recalled for glass particles
Presence of Particulate matter: Particulate matter identified as glass.
- 2026-06-17FDA-DrugBEEKEEPER'S NATURALS USA INC.Not Yet ClassifiedBeekeeper's Naturals nasal spray recalled for microbial contamination
Microbial Contamination of Non-Sterile Products
- 2026-06-11FDA-PRBeekeeper’s NaturalsBeekeeper's Naturals nasal spray recalled for microbial contamination
FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level. This lot, produced at a third-party manufacturer, tested above our acceptable
- 2026-06-03FDA-DrugAbbVie Inc.Class IIIAbbVie PRED MILD eye drops recalled for stability issue
Failed Stability Specifications
- 2026-06-03FDA-DrugAVEVA Drug Delivery Systems, Inc.Class IIIAveva nicotine patches recalled for elevated impurities
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- 2026-05-27FDA-DrugWisconsin Pharmacal CompanyClass IMG217 skin cream recalled for bacterial contamination
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
- 2026-05-27FDA-DrugSafecor Health, LLCClass IISafecor Health Nephronex vitamin supplement recalled for foreign particles
Presence of a Foreign Substance; black particles observed in liquid
- 2026-05-27FDA-DrugIntegraDose Compounding Services LLCClass IIIntegraDose fentanyl citrate injection recalled for subpotency
Subpotent Drug
- 2026-05-27FDA-DrugUCB Biosciences Inc.Class IICimzia prefilled syringes recalled for sterility concerns
Lack of Assurance of Sterility
- 2026-05-27FDA-DrugZydus Pharmaceuticals (USA) IncClass IIZydus erythromycin tablets recalled for nitrosamine impurity
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- 2026-05-27FDA-DrugZydus Pharmaceuticals (USA) IncClass IIZydus erythromycin tablets recalled for nitrosamine impurity
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- 2026-05-27FDA-DrugANI Pharmaceuticals, Inc.Class IIANI Pharmaceuticals estradiol gel recalled for defective packets
Defective Container; packets were found to be either empty or partially full.
- 2026-05-27FDA-DrugHaleon US Holdings LLCClass IIGas-X Simethicone recalled for incomplete ingredient labeling
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
- 2026-05-27FDA-DrugLupin Pharmaceuticals Inc.Class IILupin Liraglutide Injection recalled for particulate matter
Presence of particulate matter: a white thread-like structure in the cartridge
- 2026-05-27FDA-DrugSagent PharmaceuticalsClass IIISagent Busulfan Injection recalled for impurity specifications failure
Failed Impurities/Degradation Specifications
- 2026-05-27FDA-DrugSafecor Health, LLCClass IISafecor Health atomoxetine capsules mislabeled with wrong strength
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- 2026-05-27FDA-DrugAmerisource Health Services LLCClass IIIAmerisource Primidone Tablets recalled for contamination
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- 2026-05-27FDA-DrugAmerisource Health Services LLCClass IIIAmerisource Primidone tablets recalled for cross-contamination
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- 2026-05-27FDA-DrugGolden State Medical Supply Inc.Class IIIGolden State Medical Supply Primidone Tablets recalled for contamination
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- 2026-05-27FDA-DrugGolden State Medical Supply Inc.Class IIIGolden State Medical Supply Primidone recalled for API contamination
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- 2026-05-27FDA-DrugLannett Company Inc.Class IIILannett Primidone tablets recalled for API contamination
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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