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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5 Wishgarden Herbs, Incorporated Class I Terminated 20210106
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02 Fresenius Kabi USA, LLC Class II Terminated 20210106
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34 CIPLA Class II Terminated 20210106
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34 CIPLA Class II Terminated 20210106
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34 CIPLA Class II Terminated 20210106
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Strides Pharma Inc. Class III Terminated 20210106
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68 Ascend Laboratories LLC Class II Terminated 20210106
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 Ascend Laboratories LLC Class II Terminated 20210106
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979 Imprimis NJOF, LLC Class II Terminated 20210106
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05 US Compounding Inc Class III Terminated 20210106
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053 Morton Grove Pharmaceuticals, Inc. Class II Terminated 20201230
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Fresenius Kabi USA, LLC Class II Terminated 20201230
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232 SCA Pharmaceuticals, Inc. Class II Terminated 20201230
Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01 Akebia Therapeutics dba Keryx Biopharmaceutials, Inc Class II Terminated 20201230
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17 Hikma Pharmaceuticals USA Inc. Class II Terminated 20201223
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10 AVKARE Inc. Class I Terminated 20201223
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01. AVKARE Inc. Class II Terminated 20201223
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40 CIPLA Class II Terminated 20201223
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico, Barcode: 7 05333 5897 Simex Logistics SA de CV Class II Terminated 20201223
UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www.uvt.world Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico Barcode: 7 00306 88677 2 Simex Logistics SA de CV Class II Terminated 20201223
Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 1130 Ada St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente C.P. 38040 Celaya, Guanajuato, Mexico. [email protected] Barcode: 6 18149 21988 9 Simex Logistics SA de CV Class II Terminated 20201223
CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01 Simex Logistics SA de CV Class II Terminated 20201223
+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico. Simex Logistics SA de CV Class II Terminated 20201223
Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5 OZ (15 g), Distributed by The Kroger CO, Cincinnati, Ohio 45202 Made in Canada, NDC 30142-510-01 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T1C1 Distributed by Kaiser Foundation Hospitals Livemore, CA 94551-9756. Made in Canada. NDC 0179-8014-30 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.5 oz. (14.2 g), Made with Pride & Care for H-E-B San Antonio, TX 78204 Made in Canada NDC 37808-305-01 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) NET WT. 0.5 oz (14.2g), NDC 49035-812-01, b) NET WT 2 OZ (60g), NDC 49035-812-27. Distributed by: Walmart Inc., Bentonville, AR 72716. Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03 Taro Pharmaceuticals U.S.A., Inc. Class II Terminated 20201223
Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden BASF Corporation Class II Completed 20201223
Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01 Biogen MA Inc. Class II Terminated 20201223
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205 SCA Pharmaceuticals Class III Terminated 20201223
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77 Zydus Pharmaceuticals (USA) Inc Class II Terminated 20201223
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77 Zydus Pharmaceuticals (USA) Inc Class II Terminated 20201223
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN Advanced Nutriceuticals, LLC Class II Ongoing 20201223