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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 5901–5920 of 17,773 recalls

Class ITerminated

LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

ICU Medical Inc

Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

May 8, 2020 · DrugView details →
Class IIITerminated

Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4

Exela Pharma Sciences LLC

Short Fill

May 5, 2020 · DrugView details →
Class IITerminated

Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50

Mylan Institutional LLC

Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.

May 5, 2020 · DrugView details →
Class IIITerminated

Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10

Dr. Reddy's Laboratories, Inc.

Discoloration: product contains brown pellets

April 24, 2020 · DrugView details →
Class IIITerminated

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

The Harvard Drug Group

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

April 24, 2020 · DrugView details →
Class IIITerminated

R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350

QuVa Pharma, Inc.

Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac

April 23, 2020 · DrugView details →
Class IITerminated

Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0

Sandoz, Inc

Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

April 21, 2020 · DrugView details →
Class ITerminated

Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Fresenius Kabi USA, LLC

Presence of Particulate Matter - found in reserve sample vials at the firm.

April 20, 2020 · DrugView details →
Class IIITerminated

ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

April 20, 2020 · DrugView details →
Class IITerminated

Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03

Lupin Pharmaceuticals Inc.

Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.

April 20, 2020 · DrugView details →
Class IIITerminated

ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

April 20, 2020 · DrugView details →
Class IIITerminated

ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

April 20, 2020 · DrugView details →
Class IITerminated

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Fresenius Kabi USA, LLC

Presence of Particulate Matter - found in reserve sample vials at the firm.

April 20, 2020 · DrugView details →
Class ITerminated

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

B. Braun Medical Inc

Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.

April 18, 2020 · DrugView details →
Class IITerminated

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

Amneal Pharmaceuticals of New York, LLC

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

April 15, 2020 · DrugView details →
Class ITerminated

KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE.

Summitt Labs

Chemical Contamination; product contains elevated levels of lead

April 15, 2020 · DrugView details →
Class IITerminated

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433

H J Harkins Company Inc dba Pharma Pac

cGMP Deviations

April 15, 2020 · DrugView details →
Class IITerminated

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

Lupin Pharmaceuticals Inc.

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

April 15, 2020 · DrugView details →
Class IITerminated

Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100

B & B Pharmaceuticals, Inc.

cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.

April 14, 2020 · DrugView details →
Class ITerminated

Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.

MasterPharm LLC

Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.

April 14, 2020 · DrugView details →
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