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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.

by Watson Laboratories Inc

Reason: Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Recall initiated: December 23, 2013
Reported by FDA: January 15, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98

by Teva Pharmaceuticals USA

Reason: Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Recall initiated: November 26, 2013
Reported by FDA: January 8, 2014
Distribution: Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone

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Drug Recall Terminated Historical recordClass II

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

by Hospira Inc.

Reason: Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Recall initiated: October 11, 2013
Reported by FDA: January 8, 2014
Distribution: US Nationwide.

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Drug Recall Terminated Historical recordClass III

Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).

by Qualitest Pharmaceuticals

Reason: Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Recall initiated: December 16, 2013
Reported by FDA: January 8, 2014
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

by Sandoz Inc

Reason: Subpotent; Hydrochlorothiazide at the 9 month time point.
Recall initiated: October 11, 2013
Reported by FDA: January 8, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial)

by Teva Pharmaceuticals USA

Reason: Presence of Precipitate; precipitation of drug product
Recall initiated: October 11, 2013
Reported by FDA: January 8, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

by G & W Laboratories Inc

Reason: Failed Content Uniformity Specifications; at the 18 month time point.
Recall initiated: September 30, 2013
Reported by FDA: January 8, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3.

by Physicians Total Care, Inc.

Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Recall initiated: November 22, 2013
Reported by FDA: January 1, 2014
Distribution: CA, GA, NC, and MO

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Drug Recall Terminated Historical recordClass III

Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.

by Hi-Tech Pharmacal Co., Inc.

Reason: Failed Stability Specification; product viscosity and or pH are below specification.
Recall initiated: October 28, 2013
Reported by FDA: January 1, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07.

by GlaxoSmithKline, LLC.

Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Recall initiated: November 6, 2013
Reported by FDA: January 1, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00

by GlaxoSmithKline, LLC.

Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Recall initiated: November 6, 2013
Reported by FDA: January 1, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009

by Airgas Medical Services

Reason: Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Recall initiated: October 10, 2013
Reported by FDA: January 1, 2014
Distribution: To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.

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Drug Recall Terminated Historical recordClass II

Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09

by Amedra Pharmaceuticals LLC

Reason: Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Recall initiated: October 7, 2013
Reported by FDA: January 1, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691

by Tower Pharmacy and Compounding

Reason: Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
Recall initiated: November 16, 2013
Reported by FDA: January 1, 2014
Distribution: CA

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Drug Recall Terminated Historical recordClass II

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01

by Sandoz Incorporated

Reason: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Recall initiated: October 22, 2013
Reported by FDA: January 1, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Recall initiated: December 4, 2013
Reported by FDA: January 1, 2014
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02

by Hospira Inc.

Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Recall initiated: July 12, 2013
Reported by FDA: December 25, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass I

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02

by Hospira Inc.

Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Recall initiated: July 12, 2013
Reported by FDA: December 25, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11

by Fresenius Kabi USA, LLC

Reason: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Recall initiated: December 6, 2013
Reported by FDA: December 25, 2013
Distribution: Nationwide, Puerto Rico, Canada, New Zealand

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Drug Recall Terminated Historical recordClass I

PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC

by Fabscout Entertainment, Inc

Reason: Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Recall initiated: August 14, 2013
Reported by FDA: December 25, 2013
Distribution: CA, FL and UT

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Data last updated: October 2, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.