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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
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only Lupin Pharmaceuticals Inc. Class II Terminated 20211110
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only Lupin Pharmaceuticals Inc. Class II Terminated 20211110
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05 Dr. Reddy's Laboratories, Inc. Class II Terminated 20211110
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Dr. Reddy's Laboratories, Inc. Class II Terminated 20211110
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Dr. Reddy's Laboratories, Inc. Class II Terminated 20211110
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA Dr. Reddy's Laboratories, Inc. Class II Terminated 20211110
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles. Dr. Reddy's Laboratories, Inc. Class II Terminated 20211110
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. Lupin Pharmaceuticals Inc. Class III Terminated 20211103
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41 MACLEODS PHARMA USA, INC Class III Terminated 20211103
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41 MACLEODS PHARMA USA, INC Class III Terminated 20211103
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA MACLEODS PHARMA USA, INC Class III Terminated 20211103
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label) Ultra Seal Corporation Class III Terminated 20211103
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label) Ultra Seal Corporation Class III Terminated 20211103
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label) Ultra Seal Corporation Class III Terminated 20211103
North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917 Ultra Seal Corporation Class III Terminated 20211103
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label ) Ultra Seal Corporation Class III Terminated 20211103
ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label) Ultra Seal Corporation Class III Terminated 20211103
Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label) Ultra Seal Corporation Class III Terminated 20211103
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label) Ultra Seal Corporation Class III Terminated 20211103
AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15 SUN PHARMACEUTICAL INDUSTRIES INC Class III Terminated 20211103
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15 SUN PHARMACEUTICAL INDUSTRIES INC Class III Terminated 20211103
SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103
HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy Class II Terminated 20211103