Posted on June 15, 2017

Omeprazole is generic Prilosec, a popular drug for lowering stomach acid production. It has seen 11 relatively minor recalls since hitting the generic market in 2012. The biggest involved just shy of 15,000 kits and originated from CutisPharma in 2016.

Below, we’ve simplified the recall data for each of these 11 events, including manufacturers, dates, number of affected bottles, lot numbers, and reasons given for each recall.

Omeprazole Recalls

There have been 11 total recalls of Omeprazole from 2012 through 2017. Most have been quite minor, between 80 capsules and 15,000 kits each. Compare that to recalls in the millions of bottles for drugs like Lisinopril or Atorvastatin.

Comprehensive data on these recalls is hard to find, thanks to a somewhat confusing FDA data structure and confusion with Esomeprazole (Nexium) recall events. The list below simplifies all Omeprazole recall data in one easy-to-use list.

There have been no recalls of this popular generic yet in 2017.

Omeprazole Facts

Via: NIH.gov

Omeprazole is the generic form of the popular proton pump inhibitor drug Prilosec. It lowers the amount of stomach acid produced by the body. It’s used to treat gastroesophageal reflux disease (GERD) symptoms. Another use is the promotion of healing in the esophagus during recovery from erosive esophagitis (damage to the esophagus from stomach acid).

Serious side effects of Omeprazole include kidney problems, seizures, low magnesium, severe stomach pain, and bloody or watery diarrhea. More common side effects are stomach pain, headache, nausea, and vomiting.

Major Omeprazole Recalls

There haven’t really been any major Omeprazole recalls on the scale of Lisinopril recalls (1.4 million bottles) or Atorvastatin recalls (2.4 million bottles). The biggest recalls of Omeprazole to date involve less than 15,000 kits of the drug.

The three biggest recalls are a 2016 recall from CutisPharma recall affecting 14,652 kits, a 2015 recall from Cox Veterinary Laboratory of 10,571 units, and a 2013 Kremers Urban Pharmaceuticals recall that covered 3,867 bottles.

The other recalls of the drug have been relatively minor, and have generally involved small runs of a few hundred capsules each, or a few thousand grams of raw material not yet in capsule form. The list below shows the three biggest recalls. For the full list of all 11 recalls, scroll down.

  • 2016 Omeprazole recall: 14,652 kits, CutisPharma.
  • 2015 Omeprazole recall: 10,571 units, Cox Veterinary Laboratory.
  • 2013 Omeprazole recall: 3,867 bottles, Kremers Urban Pharmaceuticals.

Omeprazole Manufacturers

Via: NIH.gov

Dozens of companies manufacture Omeprazole. That’s not surprising, since the drug has been in the generic realm for several years. Below is a partial list of the drug’s makers.

  • Biochem Pharmaceutical
  • Dr. Reddy’s Laboratories
  • Emcure
  • Lupin
  • Aristo Pharmaceutical
  • Zydus Cadila
  • AHPL
  • Auris
  • Comed Chemicals
  • Kopran

Full List of All Omeprazole Recalls

The full list of all 11 FDA Omeprazole recalls is below. Some of the recalls listed are actually just part of a larger whole. For example, the first two recalls on the list happened on the same date, against the same company, for the same reason. The only difference between the two recalls is the dosage size.

Two recalls in 2015 involving nearly 13,000 units of the drug happened because two veterinary pharmaceutical companies tried to make and market Omeprazole for use in animals. That use had not yet been approved by the FDA.

Class I, II, and III Recalls

All the recalls shown here carry a Class III or Class II rating. The difference is that Class II indicates a significant (though not immediate) risk of serious injury or death, while Class III recalls involve non-life-threatening FDA violations.

Class I recalls carry a significant and immediate danger of death. As of 6/14/2017 there has never been a Class I recall of Omeprazole.

Recall Dates Shown Below

The date in the heading for each recall below is the date when the recall was classified as either Class II or Class III. The date in the first bullet point is when the recall was originally issued.

Via: NIH.gov

11/16/2016 Omeprazole Recall, Class III

  • Recall issued 10/20/2016.
  • 2 mg/mL FIRST Omeprazole, 5 oz. FIRST PPI Suspension Compounding Kit.
  • Manufactured for: CutisPharma.
  • Reason: Error on label. Incorrect declared strength.
  • 5,904 kits recalled.
  • Lot # E1396.

11/16/2016 Omeprazole Recall, Class III

  • Recall issued 10/20/2016.
  • 2 mg/mL FIRST Omeprazole, 3 oz. FIRST PPI Suspension Compounding Kit.
  • Manufactured for: CutisPharma.
  • Reason: Error on label. Incorrect declared strength.
  • 8,748 kits recalled.
  • Lot # E1414.

4/20/2015 Omeprazole Recall, Class II

  • Recall issued 11/14/2014.
  • Omeprazole, varying amounts.
  • Manufacturer: Attix Pharmaceuticals.
  • Reason: Potential for penicillin cross contamination.
  • 11,250 grams recalled.
  • All lots.

4/20/2015 Omeprazole Recall, Class II

  • Recall issued 11/14/2014.
  • Omeprazole Sodium, varying amounts.
  • Manufacturer: Attix Pharmaceuticals.
  • Reason: Potential for penicillin cross contamination.
  • 5,100 grams recalled.
  • All lots.

2/13/2015 Omeprazole Recall, Class II

  • Recall issued 1/23/2015.
  • 32 ml Gastroade Xtra (Omeprazole) paste.
  • Manufacturer: Cox Veterinary Laboratory, Inc.
  • Reason: Not approved as a new animal drug.
  • 10,571 units recalled.
  • Batch #005, UPC 091037382986.

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Via: NIH.gov

1/23/2015 Omeprazole Recall, Class II

  • Recall issued 10/31/2014.
  • Gastrotec (Omeprazole 2.28 g / Misoprostol 1.4 mg).
  • Manufacturer: Tri-Star Equine Marketing LLC.
  • Reason: Not approved as a new animal drug.
  • 1,958 units recalled.
  • All lots and expiration dates.

1/16/2014 Omeprazole Recall, Class II

  • Recall issued 7/2/2013.
  • 20 mg/ 1,100 mg Omeprazole/Sodium Bicarbonate capsule.
  • Manufacturer: Distributed by: AidaPak Service.
  • Reason: Label Mixup. May be mislabeled as Cyanocobalamin or Omega-3 Fatty Acid.
  • 210 Capsules recalled.
  • Pedigree: W003789, W003873.

1/16/2014 Omeprazole Recall, Class II

  • Recall issued 7/2/2013.
  • 20 mg/ 1,110 mg Omeprazole/Sodium Bicarbonate capsule.
  • Manufacturer: Distributed by: AidaPak Service.
  • Reason: Label Mixup. May be mislabeled as Acetaminophen, Lactobacillus Gg, or Mycophenolate Mofetil.
  • 294 Capsules recalled.
  • Pedigree: AD49399_4, AD46300_17, AD65457_22.

1/16/2014 Omeprazole Recall, Class II

  • Recall issued 7/2/2013.
  • 20 mg/ 110 mg Omeprazole/Sodium Bicarbonate capsule.
  • Manufacturer: Distributed by: AidaPak Service.
  • Reason: Label Mixup.May be mislabeled as Benzocaine/Menthol.
  • 84 Capsules recalled.
  • Pedigree: AD42584_15.

1/16/2014 Omeprazole Recall, Class II

  • Recall issued 7/2/2013.
  • 20 mg/ 1,110 mg Omeprazole/Sodium Bicarbonate capsule.
  • Manufacturer: Distributed by: AidaPak Service.
  • Reason: Label Mixup. May be mislabeled as Lactobacillus Gg or Pyridoxine Hcl.
  • 210 Capsules recalled.
  • Pedigree: AD70655_20, AD73627_35.

11/20/2013 Omeprazole Recall, Class II

  • Recall issued 9/16/2013.
  • 20 mg Omeprazole Delayed-Release Capsules, USP, 1,000 capsules per bottle.
  • Manufacturer: Distributed by: Kremers Urban Pharmaceuticals Inc.
  • Reason: Some capsules may not meet required acid resistance.
  • 3,867 bottles recalled.
  • Lot # 59627.

Conclusion

Omeprazole is the popular generic form of Prilosec, used to lower the production of stomach acid as a treatment for GERD. It has undergone 11 recalls from 2012 through 2017, though none have affected more than 15,000 units of the drug.

Omeprazole recalls have been relatively light and few in number, with most due to labeling errors or cross contamination with other drugs like penicillin.

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Disclosure: The images on this page are provided for illustration only and don’t necessarily reflect recalled products.