Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

FDA Food Class II Terminated

Diet Coke, 12 oz (355 mL) cans, packed in 12 and 24 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA

February 12, 2018 Heartland Coca-Cola Bottling Company 766,271 Cases Total units
FDA Food Class II Terminated

Grape Fanta, Grape Flavored Soda, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA

February 12, 2018 Heartland Coca-Cola Bottling Company 766,271 Cases Total units
FDA Drug Class II Terminated

Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Roa

February 9, 2018 American Pharmaceutical Ingredients LLC 75 g units
NHTSA Ongoing

Battery Isolator May Overheat

February 9, 2018 Halcore Group, Inc. 1,322 units
FDA Food Class II Terminated

Kratom capsules labeled in the following ways: 1) Divinity Kratom 10 Capsule Dietary Supplement, Divinity Product LLC, Blue Springs, MO 64015; 2) Divinity Bali Kratom, 10PK Capsules; 3) Divinity Bali

February 9, 2018 Divinity Product Distribution LLC
NHTSA Ongoing

Brake Switch may Malfunction

February 9, 2018 Chrysler (FCA US LLC) 39,456 units
FDA Drug Class II Terminated

Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highlan

February 9, 2018 American Pharmaceutical Ingredients LLC 5800 g units
FDA Drug Class II Terminated

Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed b

February 9, 2018 American Pharmaceutical Ingredients LLC 52000 g units
FDA Drug Class II Terminated

Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120

February 9, 2018 American Pharmaceutical Ingredients LLC 200000 g units
FDA Drug Class II Terminated

Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC

February 9, 2018 American Pharmaceutical Ingredients LLC 106200 g units
FDA Drug Class II Terminated

Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC

February 9, 2018 American Pharmaceutical Ingredients LLC 1,050,000 g units
FDA Drug Class II Terminated

Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland R

February 9, 2018 American Pharmaceutical Ingredients LLC 8300 g units
FDA Drug Class II Terminated

Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336-6); c) 500g (NDC 58597-8336-7); d) 1000g (NDC 58597-8336-8), RX only, packed by

February 9, 2018 American Pharmaceutical Ingredients LLC 225300 g units
FDA Drug Class II Terminated

Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 H

February 9, 2018 American Pharmaceutical Ingredients LLC 684 g units
FDA Drug Class II Terminated

Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only,

February 9, 2018 American Pharmaceutical Ingredients LLC N/A units
FDA Drug Class II Terminated

Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 665

February 9, 2018 American Pharmaceutical Ingredients LLC 1638 g units
FDA Drug Class II Terminated

Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), RX only, packed by American Pharmaceutical In

February 9, 2018 American Pharmaceutical Ingredients LLC 3675 g units
FDA Drug Class II Terminated

Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by

February 9, 2018 American Pharmaceutical Ingredients LLC 15000 g units
FDA Drug Class II Terminated

Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, p

February 9, 2018 American Pharmaceutical Ingredients LLC 192000 g units
FDA Drug Class II Terminated

Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients,

February 9, 2018 American Pharmaceutical Ingredients LLC 166000 g units
FDA Drug Class II Terminated

Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC

February 9, 2018 American Pharmaceutical Ingredients LLC 48525 g units
FDA Drug Class II Terminated

Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Phar

February 9, 2018 American Pharmaceutical Ingredients LLC 13335 g units
FDA Drug Class II Terminated

Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterfor

February 9, 2018 American Pharmaceutical Ingredients LLC 25000 g units
FDA Drug Class II Terminated

Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), RX only, packed by American Phar

February 9, 2018 American Pharmaceutical Ingredients LLC 74000 g units
FDA Drug Class II Terminated

Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), RX only, packed by American Pharmaceutical

February 9, 2018 American Pharmaceutical Ingredients LLC 26500 g units
FDA Drug Class II Terminated

Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients

February 9, 2018 American Pharmaceutical Ingredients LLC 22900 g units
FDA Drug Class II Terminated

Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6

February 9, 2018 American Pharmaceutical Ingredients LLC 5000 g units
FDA Drug Class II Terminated

Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by

February 9, 2018 American Pharmaceutical Ingredients LLC 47500 g units
FDA Drug Class II Terminated

Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, pa

February 9, 2018 American Pharmaceutical Ingredients LLC 33000 g units
FDA Drug Class II Terminated

Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Roa

February 9, 2018 American Pharmaceutical Ingredients LLC 1300 g units
FDA Drug Class II Terminated

Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highlan

February 9, 2018 American Pharmaceutical Ingredients LLC 10000 g units
FDA Drug Class II Terminated

Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650

February 9, 2018 American Pharmaceutical Ingredients LLC 10000 g units
FDA Drug Class II Terminated

Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed

February 9, 2018 American Pharmaceutical Ingredients LLC 10000 g units
FDA Drug Class II Terminated

Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by A

February 9, 2018 American Pharmaceutical Ingredients LLC 7000 g units
FDA Drug Class II Terminated

Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients,

February 9, 2018 American Pharmaceutical Ingredients LLC 12725 g units
FDA Drug Class II Terminated

Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American P

February 9, 2018 American Pharmaceutical Ingredients LLC 193000 g units
FDA Drug Class II Terminated

Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Wat

February 9, 2018 American Pharmaceutical Ingredients LLC 29550 g units
FDA Drug Class II Terminated

Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8

February 9, 2018 American Pharmaceutical Ingredients LLC 12000 g units
FDA Drug Class II Terminated

Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road,

February 9, 2018 American Pharmaceutical Ingredients LLC 75 g units
FDA Drug Class II Terminated

Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American P

February 9, 2018 American Pharmaceutical Ingredients LLC 606950 units
FDA Drug Class II Terminated

Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.

February 9, 2018 American Pharmaceutical Ingredients LLC 73 g units
FDA Drug Class II Terminated

Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by Ameri

February 9, 2018 American Pharmaceutical Ingredients LLC 116850 g units
FDA Drug Class II Terminated

Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American

February 9, 2018 American Pharmaceutical Ingredients LLC 240 g units
FDA Drug Class II Terminated

Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.

February 9, 2018 American Pharmaceutical Ingredients LLC 10000 g units
FDA Drug Class II Terminated

Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478

February 9, 2018 Apace KY LLC 630 cartons units
FDA Drug Class II Terminated

Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharma

February 9, 2018 American Pharmaceutical Ingredients LLC 12300 g units
FDA Drug Class II Terminated

Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by

February 9, 2018 American Pharmaceutical Ingredients LLC N/A units
FDA Drug Class II Terminated

Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.

February 9, 2018 American Pharmaceutical Ingredients LLC N/A units
FDA Drug Class II Terminated

Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 66

February 9, 2018 American Pharmaceutical Ingredients LLC 2100 g units
FDA Drug Class II Terminated

Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by Am

February 9, 2018 American Pharmaceutical Ingredients LLC 86225 g units