Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-09-09FDA-DrugAAA Cosmetica, SA de CVClass I
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
Chemical Contamination: Product contains methanol.
2020-09-09FDA-DrugAAA Cosmetica, SA de CVClass II
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
CGMP Deviations
2020-09-09FDA-DrugLeiper's Fork DistilleryClass II
Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
2020-09-09FDA-DrugSoluciones Cosmeticas, SA de CVClass II
Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
cGMP Deviations
2020-09-09FDA-DrugROQUE PLAST, S.A. DE C.V.Class II
Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2
CGMP Deviation: Potential contamination with undeclared methanol.
2020-09-09FDA-DrugGrato Holdings, Inc.Class II
HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1
Labeling: Error on Declared Strength
2020-09-09FDA-DrugSanta Cruz Biotechnology, IncClass II
UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220
Subpotent drug
2020-09-09FDA-DrugLaboratorios Jaloma S.A. de C.V.Class II
Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico.
cGMP deviations
2020-09-02FDA-DrugSCA PharmaceuticalsClass I
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
2020-09-02FDA-DrugSCA PharmaceuticalsClass I
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
2020-09-02FDA-DrugSCA PharmaceuticalsClass I
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
2020-09-02FDA-DrugSCA PharmaceuticalsClass I
Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
2020-09-02FDA-DrugRESOURCE RECOVERY & TRADING LLCClass II
HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013
cGMP deviations
2020-09-02FDA-DrugRESOURCE RECOVERY & TRADING LLCClass II
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020
cGMP deviations
2020-09-02FDA-DrugHetero Labs Limited (Unit V)Class II
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India
Failed Tablet/Capsule Specification; complaint of bulging tablet
2020-09-02FDA-DrugBAYSHORE PHARMACEUTICALSClass II
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01
CGMP Deviations
2020-09-02FDA-DrugBAYSHORE PHARMACEUTICALSClass II
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
CGMP Deviations
2020-09-02FDA-DrugPar Pharmaceutical Inc.Class II
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Failed Impurity /Degradation Specifications
2020-09-02FDA-DrugThe Mentholatum CompanyClass III
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
2020-09-02FDA-DrugYusef Manufacturing Laboratories, LLCClass II
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
2020-09-02FDA-DrugEcolab IncClass II
Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21
Discoloration and Presence of Foreign Substance
2020-09-02FDA-DrugFresenius Kabi USA, LLCClass I
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
Cross Contamination with other products: trace amounts of lidocaine
2020-09-02FDA-DrugAurobindo Pharma USA Inc.Class II
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
2020-09-02FDA-DrugMedichem S.A.Class I
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
2020-09-02FDA-DrugHikma Pharmaceuticals USA Inc.Class II
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01.
Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940; NDC 10702-0029-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940; NDC 10702-0028-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

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