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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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Home › All recalls › Prescription medicine

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

2,102 recalls · newest first

Food & drug recall · FDAAugust 5, 2026Highest risk

OPTIMAL BALANCE PHARMACY — Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy

Prescription medicine · OPTIMAL BALANCE PHARMACY · 53 vials affected

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Food & drug recall · FDAAugust 5, 2026Serious

Zydus Pharmaceuticals (USA) Inc — Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Food & drug recall · FDAAugust 4, 2026Highest risk

Fresenius Kabi USA, LLC — Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of

Prescription medicine · Fresenius Kabi USA, LLC · 625500 syringes affected

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Safety announcement · FDAAugust 4, 2026Worth checking

Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-up

Prescription medicine · Fresenius Kabi

FOR IMMEDIATE RELEASE – 8/4/2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot…

Food & drug recall · FDAAugust 4, 2026Serious

Novartis Pharmaceuticals Corporation — Diovan (valsartan) 160 mg, 90 tablets, Rx only

Prescription medicine · Novartis Pharmaceuticals Corporation

Failed Dissolution Specifications

Food & drug recall · FDAAugust 3, 2026Serious

Shoolin Pharma Chem LLP — TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715

Prescription medicine · Shoolin Pharma Chem LLP · 1KG - 100-0.1KG(100gm) bags affected

CGMP Deviations:Noted during FDA inspection

Food & drug recall · FDAAugust 3, 2026Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 1968 Bottles (1000Tablets/Bottle) affected

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Food & drug recall · FDAAugust 3, 2026Serious

Shoolin Pharma Chem LLP — SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat

Prescription medicine · Shoolin Pharma Chem LLP · 25 KG, 25 X 1.00 KG bags affected

CGMP Deviations:Noted during FDA inspection

Food & drug recall · FDAAugust 3, 2026Serious

Shoolin Pharma Chem LLP — SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat

Prescription medicine · Shoolin Pharma Chem LLP · 25KG, 250-1gm bags affected

CGMP Deviations:Noted during FDA inspection

Food & drug recall · FDAAugust 3, 2026Serious

Shoolin Pharma Chem LLP — TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 3827

Prescription medicine · Shoolin Pharma Chem LLP · 20 KG, 40 X 0.500KG(500gm) bags affected

CGMP Deviations:Noted during FDA inspection

Food & drug recall · FDAAugust 3, 2026Serious

Lupin Pharmaceuticals Inc. — Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only

Prescription medicine · Lupin Pharmaceuticals Inc. · 5082 tubes affected

Failed content uniformity specifications.

Food & drug recall · FDAAugust 3, 2026Serious

Shoolin Pharma Chem LLP — TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715

Prescription medicine · Shoolin Pharma Chem LLP · 1KG - 20 X 1KG(1000gm) bags affected

CGMP Deviations:Noted during FDA inspection

Food & drug recall · FDAJuly 31, 2026Highest risk

Liebel-Flarsheim Company LLC — Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution

Prescription medicine · Liebel-Flarsheim Company LLC · 3,486 500mL-vials affected

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Food & drug recall · FDAJuly 30, 2026Serious

Heritage Pharmaceuticals Inc — CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL

Prescription medicine · Heritage Pharmaceuticals Inc

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Food & drug recall · FDAJuly 29, 2026Serious

Apollo Care, LLC — SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03

Prescription medicine · Apollo Care, LLC · 9,762 vials. affected

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Food & drug recall · FDAJuly 29, 2026Serious

Apollo Care, LLC — SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02

Prescription medicine · Apollo Care, LLC · 23,029 vials. affected

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Food & drug recall · FDAJuly 29, 2026Serious

Apollo Care, LLC — SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03

Prescription medicine · Apollo Care, LLC · 250 vials. affected

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Food & drug recall · FDAJuly 29, 2026Serious

Prestige Brands Holdings — CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920

Prescription medicine · Prestige Brands Holdings · 39,060 15mL-bottles affected

Lack of assurance of sterility.

Food & drug recall · FDAJuly 29, 2026Serious

Apollo Care, LLC — SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01

Prescription medicine · Apollo Care, LLC · 37,546 vials. affected

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Food & drug recall · FDAJuly 29, 2026Serious

Shilpa Medicare Limited — PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only

Prescription medicine · Shilpa Medicare Limited · 18,434 10mL vials affected

Discolored solution.

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