Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 8, 2013 | PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple ... | Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinica... | Class III | Fresenius Kabi USA, LLC |
| Nov 6, 2013 | Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bot... | Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content duri... | Class III | Sandoz Inc |
| Nov 4, 2013 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, ... | Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr... | Class III | Greenstone Llc |
| Nov 4, 2013 | Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, R... | Failed Dissolution Specification; 8 hr stability timepoint | Class III | Pfizer Inc. |
| Oct 28, 2013 | Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx onl... | Failed Stability Specification; product viscosity and or pH are below specification. | Class III | Hi-Tech Pharmacal Co., Inc. |
| Oct 16, 2013 | Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharm... | Subpotent. drug | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Oct 2, 2013 | Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... | Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE... | Class III | Cardinal Health |
| Sep 30, 2013 | G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b... | Failed Content Uniformity Specifications; at the 18 month time point. | Class III | G & W Laboratories Inc |
| Sep 25, 2013 | Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bot... | Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate T... | Class III | Sandoz Incorporated |
| Sep 23, 2013 | Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for S... | Subpotent | Class III | Tolmar, Inc. |
| Sep 20, 2013 | Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an in... | Class III | Valeant Pharmaceuticals North Am |
| Sep 19, 2013 | ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Man... | Discoloration; due to prolonged heat exposure. | Class III | Ferring Pharmaceuticals Inc |
| Sep 16, 2013 | Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, pac... | Failed Dissolution Specification:12 hour time point at 18 months of product shelf life. | Class III | Osmotica Pharmaceutical Corp |
| Sep 11, 2013 | Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consume... | Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets. | Class III | Physicians Total Care, Inc. |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-1... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The pro... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The prod... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 9, 2013 | Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-5... | Defective Container: Stability samples of both products were noted to have some white solid produ... | Class III | PACK Pharmaceuticals, LLC |
| Sep 8, 2013 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Sep 8, 2013 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.... | Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during t... | Class III | Hill Dermaceuticals, Inc. |
| Sep 4, 2013 | GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-... | Subpotent; phenylephrine HCl | Class III | Hi-Tech Pharmacal Co., Inc. |
| Sep 3, 2013 | Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufac... | Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken t... | Class III | Novartis Consumer Health |
| Aug 30, 2013 | SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per... | Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic ... | Class III | Boehringer Ingelheim Roxane Inc |
| Aug 30, 2013 | Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 ... | Defective Container: Defective bottles may not have tamper evident seals properly seated, and th... | Class III | Watson Laboratories Inc |
| Aug 21, 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... | Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2... | Class III | Actavis South Atlantic LLC |
| Aug 7, 2013 | Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 m... | Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorg... | Class III | Sandoz Incorporated |
| Aug 6, 2013 | Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, W... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi... | Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg,... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 6, 2013 | Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be ... | Class III | Novartis Consumer Health |
| Aug 1, 2013 | Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by ... | Labeling: Incorrect Package Insert; product packaged with outdated version of the insert | Class III | AbbVie Inc. |
| Jul 31, 2013 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... | Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above appro... | Class III | Actavis Inc |
| Jul 25, 2013 | Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL... | Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes lab... | Class III | Hi-Tech Pharmacal Co., Inc. |
| Jul 19, 2013 | Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count... | Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled... | Class III | Watson Laboratories Inc |
| Jul 19, 2013 | Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (... | Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibit... | Class III | Bracco Diagnostics Inc |
| Jul 18, 2013 | ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ... | Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili... | Class III | Vi-Jon, Inc. |
| Jul 18, 2013 | TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 C... | Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable... | Class III | GlaxoSmithKline, LLC. |
| Jul 15, 2013 | Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02 | Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulti... | Class III | Braintree Laboratories Inc. |
| Jun 28, 2013 | Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (impri... | Subpotent; Beta carotene (Vitamin A) | Class III | Stayma Consulting Service, LLC. |
| Jun 28, 2013 | NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (N... | Subpotent; Beta carotene (Vitamin A) | Class III | Stayma Consulting Service, LLC. |
| Jun 28, 2013 | Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imp... | Subpotent; Beta carotene (Vitamin A) | Class III | Stayma Consulting Service, LLC. |
| Jun 28, 2013 | Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprin... | Subpotent; Beta carotene (Vitamin A) | Class III | Stayma Consulting Service, LLC. |
| Jun 28, 2013 | Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprin... | Subpotent; Beta carotene (Vitamin A) | Class III | Stayma Consulting Service, LLC. |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.