Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-407-2013 | 04-10-2013 | Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. | FVS Holdings, Inc. dba. Green Valley Drugs / 6213 vials | Class II | Terminated |
| D-889-2013 | 04-09-2013 | 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789 | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. | Total Resources Intl / | Class II | Terminated |
| D-890-2013 | 04-09-2013 | Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789 | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. | Total Resources Intl / | Class II | Terminated |
| D-891-2013 | 04-09-2013 | (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789 | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride. | Total Resources Intl / | Class II | Terminated |
| D-498-2013 | 04-09-2013 | Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India Package NDCs: 65862-037-30; 65862-037-01; 65862-037-00; 65862-037-05; 65862-037-99; 65862-038-30; 65862-038-01; 65862-038-00; 65862-038-05; 65862-038-99; 65862-039-30; 65862-039-01; 65862-039-00; 65862-039-05; 65862-039-99; 65862-040-30; 65862-040-01; 65862-040-00; 65862-040-05; 65862-040-99; 65862-041-30; 65862-041-01; 65862-041-00; 65862-041-05; 65862-041-99; 65862-042-30; 65862-042-01; 65862-042-00; 65862-042-05; 65862-042-99 | Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label | Aurobindo Pharma USA Inc / 1776 bottles | Class III | Terminated |
| D-418-2013 | 04-08-2013 | BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01 | Subpotent; Cetylpyridinum Chloride | Hi-Tech Pharmacal Co., Inc. / 10,440 bottles | Class III | Terminated |
| D-297-2013 | 04-08-2013 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25 | Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. | Hospira Inc. / 245,250 vials | Class II | Terminated |
| D-331-2013 | 04-05-2013 | Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430 Package NDCs: 68462-108-60; 68462-108-05; 68462-108-10; 68462-153-60; 68462-153-05; 68462-153-10; 68462-109-60; 68462-109-05; 68462-109-10; 68462-110-60; 68462-110-05; 68462-110-10 | Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature. | Glenmark Generics Inc., USA / 9624 bottles | Class III | Terminated |
| D-329-2013 | 04-05-2013 | Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. Package NDCs: 68462-126-01; 68462-126-05; 68462-127-01; 68462-127-05 | Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. | Glenmark Generics Inc., USA / a) 33,138 bottles (500ct) ; b)19,278 bottles (500 ct) | Class III | Terminated |
| D-330-2013 | 04-05-2013 | Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature. | Glenmark Generics Inc., USA / 246,528 bottles | Class III | Terminated |
| D-419-2013 | 04-04-2013 | Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8. | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution. | Aaron Industries Inc / 27,144 bottles | Class III | Terminated |
| D-002-2014 | 04-03-2013 | Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59 | Resuspension Problems: Recalled lot did not meet resuspendability requirements. | Boehringer Ingelheim Roxane Inc / 10,267 bottles | Class II | Terminated |
| D-019-2014 | 04-02-2013 | Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110 - Package NDCs: 10223-0202-2; 10223-0202-4; 10223-0202-5; 10223-0202-6; 10223-0202-7; 10223-0202-8; 10223-0225-1; 10223-0226-1; 10223-0202-3 | Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point. | Cetylite Industries, Inc. / 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units | Class II | Terminated |
| D-437-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 5,767,711 tablets | Class II | Terminated |
| D-438-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 21,019,909 tablets | Class II | Terminated |
| D-448-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 12,911 Bottles | Class II | Terminated |
| D-441-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 3,844,402 tablets | Class II | Terminated |
| D-440-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 13,460,920 tablets | Class II | Terminated |
| D-445-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 142,103 Bottles | Class II | Terminated |
| D-446-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 40,311 Bottles | Class II | Terminated |
| D-443-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 5,768,782 tablets | Class II | Terminated |
| D-450-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 32,345 Bottles | Class II | Terminated |
| D-451-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 29,489 Bottles | Class II | Terminated |
| D-444-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 5,771,989 tablets | Class II | Terminated |
| D-449-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 61,347 Bottles | Class II | Terminated |
| D-439-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 7,614,709 tablets | Class II | Terminated |
| D-434-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 19,787 Bottles | Class II | Terminated |
| D-436-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 12,156 Bottles | Class II | Terminated |
| D-432-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 4,440 Bottles | Class II | Terminated |
| D-447-2013 | 04-01-2013 | Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01 | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 77,471 Bottles | Class II | Terminated |
| D-435-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 9,545,718 tablets | Class II | Terminated |
| D-433-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 7,681,277 tablets | Class II | Terminated |
| D-442-2013 | 04-01-2013 | Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected. | Lloyd Inc. of Iowa / 9,575,108 tablets | Class II | Terminated |
| D-325-2013 | 04-01-2013 | ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts. | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug. | Consumer Concepts, Inc. / 11,424 blister packs | Class I | Terminated |
| D-836-2013 | 03-29-2013 | 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09. | Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates | Hospira Inc. / 691,356 containers | Class I | Terminated |
| D-417-2013 | 03-28-2013 | Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244 | Lack of Assurance of Sterility; reports of adverse events after injection | NuVision Pharmacy, Inc. / 32 vials | Class II | Terminated |
| D-257-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened | Pfizer Inc. / 37891 bottles | Class II | Completed |
| D-261-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 14464 bottles | Class II | Completed |
| D-256-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 9213 bottles | Class II | Completed |
| D-258-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 7901 bottles | Class II | Completed |
| D-254-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. / 26447 bottles | Class II | Completed |
| D-255-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. / 18195 bottles | Class II | Completed |
| D-260-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 10121 bottles | Class II | Completed |
| D-252-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 29613 bottles | Class II | Completed |
| D-253-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 37809 bottles | Class II | Completed |
| D-259-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened. | Pfizer Inc. / 36045 bottles | Class II | Completed |
| D-251-2013 | 03-28-2013 | Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Chemical contamination: emission of strong odor after package was opened.. | Pfizer Inc. / 23210 bottles | Class II | Completed |
| D-580-2013 | 03-27-2013 | Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60 Package NDCs: 0904-6007-60; 0904-6007-61; 0904-6008-60; 0904-6008-61; 0904-6009-60; 0904-6009-61 | Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 | Legacy Pharmaceutical Packaging LLC / 1,644 bottles | Class III | Terminated |
| D-877-2013 | 03-25-2013 | Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 10 vials | Class II | Terminated |
| D-876-2013 | 03-25-2013 | Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-866-2013 | 03-25-2013 | Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-865-2013 | 03-25-2013 | Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 7 vials | Class II | Terminated |
| D-873-2013 | 03-25-2013 | Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 56 vials | Class II | Terminated |
| D-864-2013 | 03-25-2013 | Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-868-2013 | 03-25-2013 | Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-860-2013 | 03-25-2013 | Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-858-2013 | 03-25-2013 | Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 408 vials | Class II | Terminated |
| D-880-2013 | 03-25-2013 | Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 12 vials | Class II | Terminated |
| D-857-2013 | 03-25-2013 | Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 1 vial | Class II | Terminated |
| D-872-2013 | 03-25-2013 | MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 18 vials | Class II | Terminated |
| D-867-2013 | 03-25-2013 | DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 3 vials | Class II | Terminated |
| D-875-2013 | 03-25-2013 | Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-859-2013 | 03-25-2013 | Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-870-2013 | 03-25-2013 | Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-861-2013 | 03-25-2013 | BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 246 vials | Class II | Terminated |
| D-874-2013 | 03-25-2013 | Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 2 vials | Class II | Terminated |
| D-871-2013 | 03-25-2013 | Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 3 vials | Class II | Terminated |
| D-881-2013 | 03-25-2013 | Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / | Class II | Terminated |
| D-878-2013 | 03-25-2013 | Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 597 vials | Class II | Terminated |
| D-869-2013 | 03-25-2013 | HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 261 vials | Class II | Terminated |
| D-863-2013 | 03-25-2013 | Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 23 vials | Class II | Terminated |
| D-879-2013 | 03-25-2013 | Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 862 vials | Class II | Terminated |
| D-862-2013 | 03-25-2013 | Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Pallimed Solutions / 71 vials | Class II | Terminated |
| D-248-2013 | 03-22-2013 | buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30. | Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point. | Actavis South Atlantic LLC / 555,672 bottles | Class III | Terminated |
| D-817-2013 | 03-22-2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Broken tablets | Watson Laboratories, Inc.-(Actavis) - Florida / 392,400 tablets | Class II | Terminated |
| D-1060-2014 | 03-22-2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles) Package NDCs: 0591-0397-60; 0591-0397-19; 0591-0398-60 | Failed Tablet/Capsule Specifications: Broken tablets | Actavis Inc / 6,540 bottles | Class II | Terminated |
| D-250-2013 | 03-21-2013 | Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080. | Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose. | Precision Dose Inc. / 9,268 cases | Class II | Terminated |
| D-673-2013 | 03-20-2013 | Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 12ml | Class II | Terminated |
| D-666-2013 | 03-20-2013 | Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / unknown | Class II | Terminated |
| D-643-2013 | 03-20-2013 | HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / N/A | Class II | Terminated |
| D-654-2013 | 03-20-2013 | Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 36ml | Class II | Terminated |
| D-653-2013 | 03-20-2013 | Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 255ml total | Class II | Terminated |
| D-680-2013 | 03-20-2013 | Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 20ml total | Class II | Terminated |
| D-660-2013 | 03-20-2013 | Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 96ml total | Class II | Terminated |
| D-636-2013 | 03-20-2013 | Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Clinical Specialties Compounding Pharmacy / 55 ml | Class II | Terminated |
| D-645-2013 | 03-20-2013 | HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / N/A | Class II | Terminated |
| D-648-2013 | 03-20-2013 | Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 10ml total | Class II | Terminated |
| D-667-2013 | 03-20-2013 | Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 7ml | Class II | Terminated |
| D-676-2013 | 03-20-2013 | Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 3ml | Class II | Terminated |
| D-651-2013 | 03-20-2013 | Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 220ml total | Class II | Terminated |
| D-650-2013 | 03-20-2013 | Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 70ml total | Class II | Terminated |
| D-647-2013 | 03-20-2013 | Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / N/A | Class II | Terminated |
| D-639-2013 | 03-20-2013 | Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Clinical Specialties Compounding Pharmacy / 95 ml total | Class II | Terminated |
| D-656-2013 | 03-20-2013 | Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 50ml total | Class II | Terminated |
| D-671-2013 | 03-20-2013 | Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 8ml | Class II | Terminated |
| D-638-2013 | 03-20-2013 | Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Clinical Specialties Compounding Pharmacy / 222 ml total | Class II | Terminated |
| D-634-2013 | 03-20-2013 | Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Clinical Specialties Compounding Pharmacy / 10ml | Class II | Terminated |
| D-679-2013 | 03-20-2013 | Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 474ml total | Class II | Terminated |
| D-646-2013 | 03-20-2013 | Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / N/A | Class II | Terminated |
| D-641-2013 | 03-20-2013 | Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Clinical Specialties Compounding Pharmacy / 18ml total | Class II | Terminated |
