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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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2,102 recalls · newest first

Food & drug recall · FDAOctober 1, 2025Serious

Aspiro Pharma Limited — Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED

Prescription medicine · Aspiro Pharma Limited

Presence of Particulate Matter: Particulate matter identified as glass

Food & drug recall · FDAOctober 1, 2025Serious

Church & Dwight Co., Inc. — ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle

Prescription medicine · Church & Dwight Co., Inc. · 21,912 bottles affected

Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.

Food & drug recall · FDASeptember 29, 2025Serious

Medline Industries, LP — Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only

Prescription medicine · Medline Industries, LP · 222,800 eaches affected

Subpotent Drug

Food & drug recall · FDASeptember 29, 2025Serious

Acella Pharmaceuticals, LLC — Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only

Prescription medicine · Acella Pharmaceuticals, LLC · 4,680 500-count bottles affected

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

Food & drug recall · FDASeptember 26, 2025Serious

Dr. Reddy's Laboratories, Inc. — Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 0854

Prescription medicine · Dr. Reddy's Laboratories, Inc. · 571 vials affected

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

Food & drug recall · FDASeptember 24, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 600 30-count bottles affected

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Food & drug recall · FDASeptember 24, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 912 30-count bottles affected

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Food & drug recall · FDASeptember 23, 2025Serious

ACME UNITED CORPORATION — Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001

Prescription medicine · ACME UNITED CORPORATION · 2338 boxes affected

Product Mix-up

Food & drug recall · FDASeptember 23, 2025Serious

Park Avenue Compounding — Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.

Prescription medicine · Park Avenue Compounding · 189 bags affected

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Food & drug recall · FDASeptember 22, 2025Serious

RC Outsourcing, LLC — Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.

Prescription medicine · RC Outsourcing, LLC · 2,669 syringes affected

Lack of assurance of sterility.

Food & drug recall · FDASeptember 19, 2025Serious

Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05)

Prescription medicine · Ascend Laboratories, LLC

Failed Dissolution Specifications

Food & drug recall · FDASeptember 19, 2025Serious

Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10)

Prescription medicine · Ascend Laboratories, LLC

Failed Dissolution Specifications

Food & drug recall · FDASeptember 19, 2025Serious

Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. I

Prescription medicine · Ascend Laboratories, LLC · 141,984 bottles affected

Failed Dissolution Specifications

Food & drug recall · FDASeptember 19, 2025Serious

Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10)

Prescription medicine · Ascend Laboratories, LLC

Failed Dissolution Specifications

Food & drug recall · FDASeptember 17, 2025Serious

Park Avenue Compounding — Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.

Prescription medicine · Park Avenue Compounding · 858 syringes affected

CGMP Deviations

Food & drug recall · FDASeptember 17, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 13824 tubes affected

CGMP Deviations: Market complaints received for gritty texture (grainy)

Food & drug recall · FDASeptember 16, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 54,432 bottles affected

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved…

Food & drug recall · FDASeptember 16, 2025Highest risk

IntegraDose Compounding Services LLC — Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1

Prescription medicine · IntegraDose Compounding Services LLC · 853/500 mL bags affected

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

Food & drug recall · FDASeptember 15, 2025Serious

Amerisource Health Services LLC — Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687

Prescription medicine · Amerisource Health Services LLC · 360 cartons affected

Failed Dissolution Specifications.

Food & drug recall · FDASeptember 15, 2025Serious

Graviti Pharmaceuticals Private Limited — Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, N

Prescription medicine · Graviti Pharmaceuticals Private Limited · 46,512/30 count bottles affected

Failed Tablet/Capsule Specifications

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