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Use caution Drug recall · FDA · Published January 11, 2016

Pfizer Recalls Lyrica Capsules Due to Deformed Units

Pfizer is recalling specific lots of Lyrica (pregabalin) capsules because some may be deformed or damaged. Check your bottle's lot number and expiration date.

🇺🇸 FDA recall #D-0649-2016DrugPfizer ›
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Recalling firmPfizer Inc.235 East 42nd Street · New York, NY 10017-5703
✎ GovInfoNow plain-language explainer

What happened, in plain English

Pfizer Inc. is recalling specific lots of Lyrica (pregabalin) capsules, 75 mg in 90-count bottles, due to the potential presence of deformed or damaged capsules. The recall affects approximately 116,400 bottles distributed nationwide and in Puerto Rico. No remedy details are currently provided in the record. Read more at govinfonow.com/recall/43269-pfizer-recalls-lyrica-capsules-due-to-deformed-units.

Source Summary by GovInfoNow · govinfonow.com/recall/43269-pfizer-recalls-lyrica-capsules-due-to-deformed-units · Updated October 11, 2026 · FDA enforcement record: FDA #D-0649-2016

Cite this page

“Pfizer Recalls Lyrica Capsules Due to Deformed Units.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43269-pfizer-recalls-lyrica-capsules-due-to-deformed-units. Based on FDA recall #D-0649-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0649-2016%22&limit=1).

Why it’s dangerous

The recalled capsules may be deformed or damaged. While the record does not specify the exact medical consequence, damaged capsules can affect the integrity of the drug delivery system for pregabalin.

Who’s affected

Patients prescribed Lyrica (pregabalin) who purchased the affected 75 mg, 90-count bottles from pharmacies or distributors across the United States and Puerto Rico. Individuals with these specific lot numbers are at risk of receiving damaged medication.

How to tell if you have this one

Check your Lyrica bottle for NDC 0071-1014-68. Look for Lot numbers M07862 with an expiration date of 05/2018, or Lot number M07865 with an expiration date of 06/2018. The product is a 75 mg, Rx-only capsule in a 90-count bottle distributed by Parke-Davis, Division of Pfizer Inc.

  • Brand
    Pfizer
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide and Puerto Rico
  • NDC
    0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015-41, 0071-1015-68, 0071-1016-41, 0071-1016-68, 0071-1017-68, 0071-1019-68, 0071-1018-68, 0071-1020-01
Recall numberProduct, codes & lotsQuantity
D-0648-2016Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68; Lot #: M07861, Exp 05/201830,672 bottles
D-0649-2016Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68; Lot #: M07862, Exp 05/2018; M07865, Exp 06/2018116,400 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Your Lot Number

    Verify if your Lyrica bottle matches the recalled lot numbers M07862 or M07865.

  2. Contact Your Pharmacist

    Speak with your pharmacy or healthcare provider to determine next steps for replacement or disposal, as no specific remedy is listed in the record.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Jan 11, 201612. FDA classified it Class II: Feb 1, 201623. Published in FDA’s Enforcement Report: Feb 10, 201634. FDA terminated the recall: Apr 24, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0649-2016 (January 11, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0649-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA