Prescription medicine recalls

Prescription medicine · Cipla USA, Inc. · 113,336 bottles affected

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Prescription medicine · Cipla USA, Inc. · 63,192 bottles affected

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Prescription medicine · Cipla USA, Inc. · 96,096 bottles affected

Cipla USA, Inc. — Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Prescription medicine · Amerisource Health Services LLC · 697 cartons affected

Amerisource Health Services LLC — Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only

Failed tablet specifications.

Food & drug recall · FDAMarch 13, 2026Serious

Cipla USA, Inc. — Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only

Prescription medicine · Cipla USA, Inc. · 54,583 syringes affected

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Food & drug recall · FDAMarch 13, 2026Serious

Cipla USA, Inc. — Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only

Prescription medicine · Cipla USA, Inc.

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

Food & drug recall · FDAMarch 13, 2026Serious

ENDO USA, Inc. — Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only

Prescription medicine · ENDO USA, Inc. · 34,293 vials affected

Crystallization; identified as Buprenorphine free base

Fresenius Kabi USA, LLC — 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 6

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, U

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-0

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20

Lack of Assurance of Sterility

Fresenius Kabi USA, LLC — 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, U