FDA Recalls Prescription Drugs

When it’s determined that a drug poses a health risk to patients, the medication can be recalled. According to the FDA, a “drug is removed from the market when its health risks or safety issues outweigh its benefits. Once a drug approved by FDA, they continue monitor the product before reaching the market. The FDA updates drug labels to keep patients and doctors informed about health risks and interactions with other drugs.

Why FDA Recalls Prescription Drugs? Reasons for Pulling a Drug From the Market

Risk of Health Problems, increased risk of kidney failure, heart attack, stroke, and other serious complications.

Manufacturing and Packaging Errors, contamination, or a packaging error may unseal a drug before it reaches the patient.

Drug Interactions, cause health risks when taken with foods, another drug, or a certain type of vitamin.

32 FDA Recalls Prescription Drugs - FDA Activities and Concerns
32 FDA Recalls Prescription Drugs – FDA Activities and Concerns

The list below provides information gathered from various portals and press releases about FDA recalls prescription drugs, certain recalls of FDA-regulated drugs. Not all recalls, only most selling prescribed drugs are posted on this page.

32 FDA Recalls Prescription Drugs

Technically, the FDA doesn’t ‘order’ a recall. When, based on the new data, packaging fault or some new health issues, if it is clear that the medicine is no longer acceptable in terms of safety, most often drug companies recall their own products when the FDA requests it.

1) Bextra (Valdecoxib)

Bextra was approved by the FDA on November 16, 2001, quickly becoming a top selling drug. It is on the market for 3.3 years.

Use: A non-steroidal anti-inflammatory drug (NSAID) for the treatment of arthritis, although  again without causing undue stress on the stomach. The FDA ordered the Bextra recall on April 7, 2005, and Pfizer immediately complied.

Manufacturer: G.D. Searle & Co., Nov. 20, 2001 to Apr. 7, 2005. Developed by Pfizer in the late 90s.

2) Posicor (Mibefradil)

Posicor, manufactured by Roche Laboratories, approved on June 20, 1997, it came on the market in August of that year. Six months after approval, the FDA announced that it had  “received reports of dangerously lowered heart rates in about 20 patients,” and Posicor could not be taken in conjunction with antihistamine Hismanal (astemizole), Propulsid (cisapride) for nighttime heartburn, Seldane (terfenadine), and cholesterol-lowering drugs. Posicor (Mibefradil) on the market for less than one year

Use: Calcium channel blocker (used to treat hypertension), marketed to treat high blood pressure and chest pain

Manufacturer: Roche Laboratories

3) Sibutramine (MERIDIA)

Manufactured by Abbott Laboratories, Meridia was approved by the FDA in November 1997,  later in October 2010, FDA finally banned this diet drug. 13 years on the market.

Reason: Safety reasons, including increased heart attacks and strokes.

Use: “Weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease” – written by FDA.

4) Paxil (Paroxetine)

Use: Selective serotonin reuptake inhibitor (SSRI), used to treat Anxiety and Stress, Major Depressive and it is the first SSRI approved by the FDA to treat panic attacks.

Reason: FDA reported in 2006 that 11 suicide attempts had occurred in patients given Paxil in trials.

It is considered more dangerous to a fetus, and women are urged to avoid it during pregnancy. FDA study shows that pregnant women who take Paxil during the first trimester have double the risk of having a baby with a heart defect, compared to other women. Paxil was reclassified as a grade D for safety during pregnancy.

Market in 1992 by GlaxoSmithKline

5) Actos (pioglitazone)

Received FDA approval in 1999 (Actos was the tenth-best selling drug in the U.S. in 2008, with sales exceeding $2.4 billion)

Use: Diabetes Drugs, Pioglitazone is used to lower blood glucose levels in the treatment of diabetes mellitus type 2 (T2DM) either alone or in combination with a sulfonylurea, metformin, or insulin.

Reason: in 2007, FDA added a black-box warning to the label, warning patients of the risk of heart failure. Later in 2011, the FDA added another warning of bladder cancer to the Actos (pioglitazone) label.

On June 9, 2011 the French Agency for the Safety of Health Products decided to withdraw pioglitazone in regards to high risk of bladder cancer. On August 17, 2012 the US FDA announced its approval of the first generic version of Actos.

6) Vioxx (Rofecoxib)

Vioxx approved in 1999 and was one of the most prescribed drug in 2003. Vioxx on the market for 5.3 years. On September 30, 2004, Merck announced a worldwide withdrawal of the drug.

Reason: Increased risk of heart attack and stroke, linked to about 27,785 heart attacks or sudden cardiac deaths between May 20, 1999 and 2003.

Use: NSAID (pain relief), anti-inflammatory medication to treat arthritis.

Manufacturer: Merck May 20, 1999 to Sep. 30, 2004

7) Zelmid (Zimelidine)

  •  No market, 1982 to 1982 (withdrawn by the FDA before being released in the US market)
  • Use: Anti-depressant
  • Manufacturer: Astra AB (now AstraZeneca) 

Related Article: Painkiller Medicines Banned Around the World, But not in India

8) Trasylol (Aprotinin)

  • Use: antifibrinolytic to reduce blood loss during surgery
  • Manufacturer: Bayer 1993 (but used since the 1960s) to Nov. 5, 2007 (marketing suspension request to phase it out of the market), 15 (48 years) on the market. May 14, 2008 (manufacturer announced complete removal from market)

9) Redux (Dexfenfluramine)

  • 1 Year on the market, 1996 to Sep. 15, 1997
  • Use: Appetite suppressant
  • Manufacturer: Wyeth-Ayerst 

10) DBI (Phenformin)

  • 19 Years on the market, 1959 to Nov. 1978
  • Use: antidiabetic
  • Manufacturer: Ciba-Geigy 

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11) Mylotarg (Gemtuzumab Ozogamicin)

  • 10 Years on the market, May 2000 to June 21, 2010
  • Use: Acute myeloid leukemia (AML, a bone marrow cancer)
  • Manufacturer: Wyeth 

12) Raptiva (Efalizumab)

  • 6 Years on the market, 2003 to Apr. 8, 2009(completely withdrawn by June 8, 2009)
  • Use: Psoriasis
  • Manufacturer: Genentech 

13) Duract (Bromfenac)

  • 1 Year on the market, July 1997 to June 26, 1998
  • Use: Pain killer
  • Manufacturer: Wyeth-Ayerst Laboratories

14) Hismanal (Astemizole)

  • 11 Years on the market, 1988 to Aug. 13, 1999
  • Use: Antipsychotic
  • Manufacturer: Janssen Pharmaceutica 

15) Seldane (Terfenadine)

  • 13 Years on the market, 1985 to Feb. 1, 1998
  • Use: Antihistamine
  • Manufacturer: Hoechst Marion Roussel (now Sanofi-Aventis)

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16) Zelnorm (Tegaserod maleate)

  • 4.6 Years on the market, July 24, 2002 to Mar. 30, 2007
  • Use: irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55
  • Manufacturer: Novartis 

17) Merital & Alival (Nomifensine)

  • 3 Years on the market, 1982 to 1985
  • Use: Antidepressant
  • Manufacturer: Hoechst AG (now Sanofi-Aventis) 

18) Micturin (Terodiline)

  • 2 Years on the market, Aug. 1989 to Sep. 13, 1991
  • Use: Bladder incontinence
  • Manufacturer: Forest Labs 

19) Omniflox (Temafloxacin)

  • 4 Months on the market, Jan. 31, 1992 to June 5, 1992
  • Use: Antibiotic for pneumonia, bronchitis, and other respiratory tract infections; prostatitis and other genitourinary tract infections; skin ailments
  • Manufacturer: Abbot Laboratories 

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20) Lotronex (Alosetron)

  • 0.8 Year on the market, Feb. 9, 2000 to Nov. 28, 2000
  • Use: Irritable bowel syndrome (IBS) in women
  • Manufacturer: Prometheus Laboratories, Inc. 

21) Selacryn (Tienilic acid)

  • 3 Years on the market, May 2, 1979 to 1982
  • Use: blood pressure
  • Manufacturer: SmithKline

22) Propulsid (Cisapride)

  • 7 Years on the market, 1993 to July 14, 2000
  • Use: Severe nighttime heart burn associated with gastro esophageal reflux disease (GERD)
  • Manufacturer: Janssen Pharmaceutica 

Read The Most Bizarre Medical Treatment: Bizarre Medicines in the Middle AgesDangerous Medieval Medical Treatments

23) PTZ & Metrazol (Pentylenetetrazol)

  • 48 Years on the market, 1934 to 1982
  • Use: Convulsive therapy for schizophrenia and other psychiatric conditions
  • Manufacturer: not known

24) Quaalude (Methaqualone)

Marketed as: Sopor, Optimal, Somnafac, Parest, and Bi-Phetamine T

  • 23 Years on the market, 1962 to 1985
  • Use: Sedative and hypnotic
  • Manufacturer: William H. Rorer Inc. & Lemmon Company

25) Pondimin (Fenfluramine)

  • 24 Years on the market, 1973 to Sep. 15, 1997
  • Use: Appetite suppressant
  • Manufacturer: Wyeth-Ayerst 

26) Palladone (Hydromorphone hydrochloride, extended-release)

  • 6 Months on the market, Jan. 2005 to July 13, 2005
  • Use: Narcotic painkiller
  • Manufacturer: Purdue Pharma

27) DES (Diethylstibestrol)

  • 31 Years on the market, 1940 to 1971
  • Use: Synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications
  • Manufacturer: Grant Chemical Co. 

28) Raplon (Rapacuronium)

  • 2 Years on the market, 1999 to Mar. 27, 2001
  • Use: Non-polarizing neuromuscular blocker (used in anesthesia)
  • Manufacturer: Organon Inc.

Read: 79 Fixed Dose Combinations of Paracetamol Banned by Ministry of Health

29) Raxar (Grepafloxacin)

  • 2 Years the on the market, 1997 to Nov. 1, 1999
  • Use: Antibiotic for bacterial infections
  • Manufacturer: Glaxo Wellcome

30) Ergamisol (Levamisole)

  • 11 Years on the market, May 8, 1989 to 2000
  • Use: Worm infestation; colon and breast cancers; rheumatoid arthritis
  • Manufacturer: Janssen Pharmaceutica

31) Rezulin (Troglitazone)

  • 3.25 Years on the market, Jan. 29, 1997 to Mar. 21, 2000
  • Use: Antidiabetic and anti-inflammatory
  • Manufacturer: Parke-Davis/Warner Lambert (now Pfizer)

 32) Xigris (Drotrecogin alfa (activated))

  • 10 Years on the market, Nov. 2001 to Oct. 25, 2011
  • Use: Severe sepsis and septic shock
  • Manufacturer: Eli Lilly & Company

If a company refuses, the FDA’s recourse is to take the company to court for an injunction–but that rarely has to happen, most of the companies recall their own drugs immediately. FDA Recalls Prescription Drugs – Sharing is caring, please comment below.

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