Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-11-10FDA-DrugBryant Ranch Prepack, Inc. dba BRP PharmaceuticalsClass IMethocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
- 2021-11-10FDA-DrugLupin Pharmaceuticals Inc.Class IIIrbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- 2021-11-10FDA-DrugLupin Pharmaceuticals Inc.Class IIIrbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- 2021-11-10FDA-DrugLupin Pharmaceuticals Inc.Class IIIrbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- 2021-11-10FDA-DrugLupin Pharmaceuticals Inc.Class IIIrbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- 2021-11-10FDA-DrugLupin Pharmaceuticals Inc.Class IIIrbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
- 2021-11-10FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. 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
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
- 2021-11-10FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. 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
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- 2021-11-10FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. 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
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- 2021-11-10FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. 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
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- 2021-11-10FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. 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.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
- 2021-11-03FDA-DrugLupin Pharmaceuticals Inc.Class IIIGatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2021-11-03FDA-DrugMACLEODS PHARMA USA, INCClass IIIRizatriptan 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
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- 2021-11-03FDA-DrugMACLEODS PHARMA USA, INCClass IIIRizatriptan 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
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- 2021-11-03FDA-DrugMACLEODS PHARMA USA, INCClass IIIRizatriptan 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
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIAfassco 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)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIXpect 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)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIAdvance 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)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIINorth 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
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIAERO 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 )
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIZEE+ 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)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIVica-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)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIPainAway 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)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIIAllerClear 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
Failed Moisture Limits
- 2021-11-03FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIILoratadine-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
Failed Moisture Limits
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IISODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIPROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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