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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Various Medications Recalled for Defective Tablet Delivery System

Agency Publication Date: November 2, 2018
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Summary

Teva Pharmaceuticals has recalled 130,514 bottles and bulk containers of Paliperidone, Fortamet (metformin), Metformin Hydrochloride, and Actoplus Met XR (pioglitazone/metformin) extended-release tablets. These medications are being recalled because some tablets may be missing a critical laser-drilled hole that is necessary for the drug to be released correctly into the body. This defect was identified across several different strengths and bottle sizes of these prescription medications sold throughout the United States.

Risk

The missing laser drilling on these extended-release tablets can prevent the medication from being released at the proper rate. This may result in the patient receiving too little of the medication or the drug not working as intended to manage their condition.

What You Should Do

  1. Check your prescription bottles for the following product names and lot numbers: Paliperidone 3 mg (Lots 1220221A, 1269627A, 1274295A, 1220222A, 1270501A, 1274296A, 1288766A); Paliperidone 9 mg (Lots 1291192A, 1291193A); Fortamet 1000 mg (Lots 1237868A, 1248900A); or Metformin 500 mg (Lot 1210888A).
  2. Also check for Metformin 1000 mg (Lots 1139500A, 1240343A, 1248901M, 1256614M, 1240400A, 1293935M) and bulk containers of Actoplus Met XR (Lots 1250668, 1274150).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are taking these medications, as you should not stop taking prescribed medication without a replacement plan.
  4. Return any unused tablets from the affected lots to your pharmacy for a refund and to obtain a safe replacement.
  5. Contact Teva Pharmaceuticals or the specific distributor listed on your bottle (Actavis Pharma, Shionogi, or Takeda) for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Paliperidone Extended Release Tablets 3 mg (30-count bottle)
Model:
NDC 0591-3693-30
Lot Numbers:
1220221A (Exp 03/2019)
1269627A (Exp 09/2019)
1274295A (Exp 10/2019)
Product: Paliperidone Extended Release Tablets 3 mg (90-count bottle)
Model:
NDC 0591-3693-19
Lot Numbers:
1220222A (Exp 03/2019)
1270501A (Exp 09/2019)
1274296A (Exp 10/2019)
1288766A (Exp 01/2020)
Product: Paliperidone Extended Release Tablets 9 mg (30-count bottle)
Model:
NDC 0591-3695-30
Lot Numbers:
1291192A (Exp 01/2020)
Product: Paliperidone Extended Release Tablets 9 mg (90-count bottle)
Model:
NDC 0591-3695-19
Lot Numbers:
1291193A (Exp 01/2020)
Product: Fortamet (metformin HCl) extended release tablets 1000 mg (60-count bottle)
Model:
NDC 59630-575-60
Lot Numbers:
1237868A (Exp 05/2020)
1248900A (Exp 05/2020)
Product: Metformin Hydrochloride Extended Release Tablets 500 mg (100-count bottle)
Model:
NDC 00591-2411-01
Lot Numbers:
1210888A (Exp 03/2019)
Product: Metformin Hydrochloride Extended Release Tablets 1000 mg (60-count bottle)
Model:
NDC 00591-2720-60
Lot Numbers:
1139500A (Exp 04/2019)
1240343A (Exp 05/2020)
1248901M (Exp 05/2020)
1256614M (Exp 05/2020)
Product: Metformin Hydrochloride Extended Release Tablets 1000 mg (90-count bottle)
Model:
NDC 00591-2412-19
Lot Numbers:
1240400A (Exp 05/2019)
1293935M (Exp 12/2019)
Product: Actoplus Met XR (Pioglitazone and metformin HCl extended-release) tablets 15 mg/1000 mg (fiber drum)
Lot Numbers:
1250668 (Exp 05/2020)
1274150 (Exp 10/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80790
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Takeda; Actavis Pharma; Shionogi Inc.; Pharmacies nationwide
Manufactured In: United States
Units Affected: 5 products (27,816 bottles; 3,785 bottles; 13,225 bottles; 3,397 bottles; 82,291 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.