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.
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIPHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIneostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IImorphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIIMorphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IILidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IILidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIlabetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIKetamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIHYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIHYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIGlycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIfentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIEsmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIBuffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugSCA PharmaceuticalsClass IIAtropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- 2021-01-13FDA-DrugAscend Laboratories LLCClass IICephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
- 2021-01-13FDA-DrugMerck Sharp & DohmeClass IIZerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
- 2021-01-06FDA-DrugWishgarden Herbs, IncorporatedClass IGoldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- 2021-01-06FDA-DrugWishgarden Herbs, IncorporatedClass ICord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- 2021-01-06FDA-DrugWishgarden Herbs, IncorporatedClass IHappy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
- 2021-01-06FDA-DrugFresenius Kabi USA, LLCClass IIKetorolac 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
Presence of Particulate Matter - found in reserve sample vials at the firm.
- 2021-01-06FDA-DrugCIPLAClass IIEsomeprazole 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
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- 2021-01-06FDA-DrugCIPLAClass IIEsomeprazole 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
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- 2021-01-06FDA-DrugCIPLAClass IIEsomeprazole 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
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- 2021-01-06FDA-DrugStrides Pharma Inc.Class IIINDC 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
Failed Moisture Limits
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief