Hazard Type

Product Quality Recalls

2,865 product recalls involving product quality. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

2,865Total Recalls
260Critical
322.2MUnits Affected
All Recalls

Every Product Quality Recall

Sorted by most recent. Click any recall for full details and safety information.

2,865 recalls
High RiskFDA
Teva Pharmaceuticals Usa
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufact...
Oral Drugs·15,329 affected·Jun 2, 2020
High RiskFDA
World Event Promotions, Llc
Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094
Drugs·14,050 affected·Jun 1, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceutica...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals ...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 0...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 ND...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Br...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. ...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals P...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LL...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceutical...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals ...
Oral Drugs·192 affected·May 29, 2020
High RiskFDA
Pfizer Inc.
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Divis...
Injectable Drugs·94,320 affected·May 29, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceutical...
Oral Drugs·0 affected·May 29, 2020
High RiskFDA
Quva Pharma, Inc.
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Driv...
Injectable Drugs·648 affected·May 28, 2020
High RiskFDA
Apotex Inc.
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario C...
Oral Drugs·305,963 affected·May 27, 2020
RecallFDA
Aurobindo Pharma Usa Inc.
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aur...
Oral Drugs·7,547 affected·May 26, 2020
Medium RiskFDA
Unichem Pharmaceuticals Usa Inc
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, P...
Oral Drugs·190,992 affected·May 26, 2020
RecallFDA
Aurobindo Pharma Usa Inc.
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aur...
Oral Drugs·13,322 affected·May 26, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharet...
Oral Drugs·29,304 affected·May 22, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alphar...
Oral Drugs·112,140 affected·May 22, 2020
CriticalFDA
Acella Pharmaceuticals, Llc
NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Al...
Oral Drugs·49,128 affected·May 22, 2020
High RiskFDA
Triova Pharmaceuticals Llc
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
Drugs·210 affected·May 15, 2020
RecallFDA
Invagen Pharmaceuticals, Inc.
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manuf...
Oral Drugs·2,202 affected·May 14, 2020
High RiskFDA
West-ward Columbus Inc
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx on...
Oral Drugs·68,376 affected·May 13, 2020
RecallFDA
West-ward Columbus Inc
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC...
Oral Drugs·3,336 affected·May 13, 2020
CriticalFDA
Icu Medical Inc
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Injectable Drugs·93,648 affected·May 8, 2020
RecallFDA
Quva Pharma, Inc.
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloo...
Drugs·17,050 affected·Apr 23, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number ...
Medical Implants·4,172 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 7133184...
Medical Implants·1,267 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 7133...
Medical Implants·1,766 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 4...
Medical Implants·1,450 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number ...
Medical Implants·58 affected·Apr 22, 2020
CriticalFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials p...
Injectable Drugs·5,314,400 affected·Apr 20, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Si...
Injectable Drugs·3,497,575 affected·Apr 20, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United State...
Oral Drugs·4,518 affected·Apr 15, 2020
High RiskFDA
Golden State Medical Supply Inc.
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bot...
Oral Drugs·0 affected·Apr 3, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Ther...
Drugs·7,957 affected·Mar 31, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Thera...
Drugs·5,614 affected·Mar 31, 2020
High RiskFDA
Noven Therapeutics, Llc
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Thera...
Drugs·14,142 affected·Mar 31, 2020
High RiskFDA
Par Pharmaceutical Inc.
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par...
Oral Drugs·29,352 affected·Mar 30, 2020
High RiskFDA
Avet Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 2315...
Oral Drugs·12,168 affected·Mar 26, 2020
High RiskFDA
Avet Pharmaceuticals, Inc.
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10)...
Oral Drugs·2,904 affected·Mar 26, 2020
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pha...
Oral Drugs·0 affected·Mar 25, 2020
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pha...
Oral Drugs·0 affected·Mar 25, 2020
High RiskFDA
Teva Pharmaceuticals Usa
LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Phar...
Oral Drugs·0 affected·Mar 25, 2020
RecallFDA
Akorn Inc
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lak...
Injectable Drugs·15,170 affected·Mar 25, 2020