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The Recall Registry is not a government service and does not issue recalls. We gather published recall notices from the U.S. Consumer Product Safety Commission, the U.S. Food and Drug Administration and the National Highway Traffic Safety Administration, and rewrite them in plain language. Always confirm the details with the issuing agency using the link on each recall page.

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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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Highest riskSeriousWorth checkingLabelling issueTap any recall for the hazard and what to do

1,991 recalls · newest first

Food & drug recall · FDAJune 11, 2025Labelling issue

Orient Pharma Co., Ltd. Yunlin Plant — Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets

Prescription medicine · Orient Pharma Co., Ltd. Yunlin Plant · 57504 bottles affected

Failed Impurities/Degradation Specifications.

Food & drug recall · FDAJune 11, 2025Labelling issue

Macleods Pharmaceuticals Ltd — Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only

Prescription medicine · Macleods Pharmaceuticals Ltd · 9,888/ 30 count bottles affected

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

Food & drug recall · FDAJune 10, 2025Serious

IMMUNOCORE, LLC — KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore

Prescription medicine · IMMUNOCORE, LLC · 7,572 vials affected

Subpotent Drug

Food & drug recall · FDAJune 6, 2025Highest risk

Church & Dwight Inc — ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton

Prescription medicine · Church & Dwight Inc · 13,632 cartons affected

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

Food & drug recall · FDAJune 6, 2025Highest risk

Church & Dwight Inc — Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton

Prescription medicine · Church & Dwight Inc · 695,880 cartons affected

Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.

Food & drug recall · FDAJune 2, 2025Serious

Tailstorm Health INC — KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 8

Prescription medicine · Tailstorm Health INC · 14,725 vials affected

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Food & drug recall · FDAJune 2, 2025Highest risk

Amneal Pharmaceuticals, LLC — Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50

Prescription medicine · Amneal Pharmaceuticals, LLC · 6396 bottles affected

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Food & drug recall · FDAJune 2, 2025Serious

Tailstorm Health INC — BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For

Prescription medicine · Tailstorm Health INC · 975 vials affected

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Food & drug recall · FDAJune 2, 2025Serious

Tailstorm Health INC — LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Dru

Prescription medicine · Tailstorm Health INC · 29,700 vials affected

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Food & drug recall · FDAJune 2, 2025Serious

Tailstorm Health INC — KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler

Prescription medicine · Tailstorm Health INC · 23,200 vials affected

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Food & drug recall · FDAJune 2, 2025Serious

Tailstorm Health INC — LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounde

Prescription medicine · Tailstorm Health INC · 2825 vials affected

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Food & drug recall · FDAJune 2, 2025Serious

Tailstorm Health INC — LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158

Prescription medicine · Tailstorm Health INC · 4875 vials affected

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Food & drug recall · FDAMay 30, 2025Serious

Advanced Pharmaceutical Technology, Inc. — TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 Sout

Prescription medicine · Advanced Pharmaceutical Technology, Inc. · 26 vials affected

Marketed Without an Approved NDA/ANDA

Food & drug recall · FDAMay 30, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 11,616 bottles affected

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules.

Food & drug recall · FDAMay 29, 2025Labelling issue

Macleods Pharmaceuticals Ltd — Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only

Prescription medicine · Macleods Pharmaceuticals Ltd · 1,344- 1000 count bottles affected

Presence of a foreign substance: black hair found embedded in tablet.

Food & drug recall · FDAMay 28, 2025Serious

Apotex Corp. — Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4

Prescription medicine · Apotex Corp. · 105,456 Bottles affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 28, 2025Serious

Apotex Corp. — Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only

Prescription medicine · Apotex Corp. · 20,648 bottles affected

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

Food & drug recall · FDAMay 28, 2025Serious

Pfizer Inc. — DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy

Prescription medicine · Pfizer Inc. · 98,410 vials affected

Discoloration; discolored solution from cracked vials

Food & drug recall · FDAMay 28, 2025Serious

Apotex Corp. — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only

Prescription medicine · Apotex Corp. · 87,840 bottles affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 28, 2025Serious

Apotex Corp. — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile

Prescription medicine · Apotex Corp. · 6,288 Bottles affected

Lack of Assurance of Sterility

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